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Biogen

A Biotechnology company.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.

Headquarter Location:
Cambridge, Massachusetts, USA

Biogen is hiring a Remote Senior Manager, Digital Engagement Data & Analytics

Job Description

About this role:

The Senior Manager, Techno-Functional Analyst, Digital Engagement Data & Analytics will enable markets to measure the effectiveness of their omnichannel campaigns and optimize their digital engagement strategies. The role is an expert on the functionality of applied data and analytics solutions and configures the capabilities according to business requirements. The individual works closely with various teams and stakeholders on local and global levels to understand the business process, define functional requirements, and design appropriate capability solutions. Further, the role runs the implementation process and manages testing, to ensure data and analytics capabilities that enable relevant customer solutions.

What you will do:

Work with business stakeholders to define business requirements and translate them into specifications for customized configurations and/or development, taking system requirements and limitations into account. The scope covers an integrated measurement framework for all digital assets and marketing programs, including for example tagging strategy for web analysis.

In coordination with the IT Data and Analytics team, design the data delivering capability systems, custom programs, front-end applications, and integrations, to enable best practice end-to-end digital data flows into the data warehouse, to meet users’ analytical needs. The scope includes for example web analytics, customer conversions, identity and access management, and customer experience feedback.

Define relevant performance KPIs for the data and analytics capabilities and monitor the performance to identify optimization opportunities. Implement capability configurations, applying best practice relative to application and/or its integrations, to optimize the capability in terms of meeting stakeholder needs.

Perform comprehensive testing of the data and analytics capabilities to ensure that solutions function as intended, avoid unintended behaviour, and identify opportunities for optimization.

Coordinate with stakeholders across cross functional technical teams to achieve the intended and aligned outcomes.

Qualifications

Who you are:

  • BA or Master’s degree or equivalent experience
  • 7+ years of proven experience in data analytics (mobile and web) and digital data management, including requirements definition and management.
  • A deep understanding and knowledge of digital data and excellent ability to bridge the gap between digital and "traditional" data, including system design and analysis.
  • Proven knowledge over 5+ years of digital technology and associated resources to configure data and analytics software based on business requirements, including user experience design and analysis. 
  • Direct experience in implementing the fundamental elements of IT required to implement global or regional digital resources, including process analysis, functional testing, regression testing.
  • Strong knowledge of technical data and analytics platforms and motivation to always stay up-to-date and innovate.

Other Job Requirements 

  • Understanding of Life Sciences commercial model
  • Excellent written, oral, presentation and communication skills in English
  • Experience with agile methodology
  • Ability to manage multiple tasks, good project management skills. 
  • Ability to work from strategy to execution.
  • Direct approach and positive attitude 
  • Experience working in a matrix structure and collaborating with teams both cross-functionally and across geographies.
  • Problem-solving and critical thinking skills

Tools & Solutions:

  • Excellent expertise in: AT Piano, Google Analytics/Ads/GTM, Adobe Analytics, Excel 
  • Excellent expertise in SQL (particularly in Snowflake)  
  • A plus: Veeva CRM, Observepoint, understanding of AI, predictive analytics models for digital analytics data 

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Biogen is hiring a Remote Associate Medical Director, US Medical Affairs, Alzheimer's

Job Description

About this role

The Associate Medical Director - Alzheimer’s role is a part of US Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes.  As a key member of the US Specialty Care Medical Director Office team and reporting to the Head of Medical Director Office, Specialty Care, the Associate Medical Director - Alzheimer’s is responsible for supporting the development and implementation of the US Medical Strategy for Alzheimer’s. Biogen’s priority is to continue to foster and enable a diverse and inclusive workforce – representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities – that reflects the communities where we operate and the patients who we serve.

What You’ll Do

  • Contribute to the development and execution of the US medical strategy and tactics for Alzheimer’s Disease assets, as aligned with Alliance and global strategy.
  • Serve as a key US Medical contact for important cross-functional partners (e.g. Global Medical, Commercial, Market Access, Training). 
  • Collaborate with global medical and with alliance partner to ensure medical activities are aligned with medical strategy and that Global Medical and Alliance Partners are sufficiently aware of the US-based insights and needs.
  • Understand the local business needs and provide insights to the local commercial teams to ensure their plans are in alignment with the medical strategy.
  • As a content expert, contribute to the development/adaptation of medical materials consistent with DSMR/PRC requirements (e.g. presentations, training materials, medical briefs and talking points) for internal colleagues as well as proactive and reactive resources for use in engagements with external stake holders.
  • As appropriate, provides leadership and strategic direction to Biogen stakeholders in interactions and communications with external customers, medical experts, and key organizations. Participate actively in external events such as congresses, advisory boards, HCP engagements as needed.
  • Build and nurture relationships with external stakeholders (including KMEs, healthcare institutions and advocacy groups) in the Alzheimer’s therapeutic area.

Who You Are

You are a scientific or clinical professional with a passion for science and deep scientific knowledge.  You have a marked curiosity about healthcare and business opportunities.  You keep patients, payers, and physicians top of mind in your daily work and collaborate to solve critical scientific and business challenges.

Qualifications

Required skills

  • MD, PhD, PharmD, DNP, or comparable advanced degree is required.
  • Minimum of 3 years of pharmaceutical industry experience, preferably with prior work in Headquarters-based Medical Affairs role &/or Field Medical based role.  Substitution of industry work with relevant clinical practice experience in neurology or immunology may be considered. 
  • Travel up to 20%

Preferred Skills

  • Clinical experience and subject matter expertise in the respective therapeutic area is optimal (Alzheimer’s Disease, Neuroscience, Immunology)
  • Experience with medical launch as well as products at different stages of the lifecycle
  • Strong working knowledge of US regulations as relevant to Medical Affairs
  • Demonstrated ability to effectively lead and collaborate with global, regional and/or affiliate medical to ensure regional activities are executed in alignment with global medical strategy and ensuring the insights and needs from them are known and properly addressed

The base compensation range for this role is $158,700.00 - $264,600.00. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions. Must be able to support EST work hours.

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Biogen is hiring a Remote Global Associate Medical Director, Lupus

Job Description

About This Role

The Associate Medical Director, Global Medical Affairs, Lupus will be a strategic partner providing expert medical leadership to guide development, launch planning, and support for our Lupus program to improve meaningful patient outcomes. As a key member of the Lupus Global Medical Affairs team, the Associate Medical Director will support development and implementation of the Global Medical Strategy for Biogen’s Lupus therapeutic area pipeline products and will help advance Biogen’s leadership in the global Lupus medical community. 

What You’ll Do

  • Build and maintain close partnership with key medical experts and healthcare providers to bring insights into the Global Medical affairs strategy.
  • Support development and implementation of cross-functionally aligned medical strategies in support of clinical development programs and eventual launch planning activities.
  • Generate medical insights to inform medical and broader cross-functional strategic and tactical plans.
  • Lead high impact medical activities such as advisory boards, medical education, and medical research projects.
  • Partner with clinical development and operations teams to support clinical development programs through enhanced site engagement activities and identification of centers of excellence.
  • Partner with scientific communications to support development and execution of publication plans for impactful data dissemination and medical education strategies.
  • Identify and advance productive collaborations with external stakeholders including healthcare and patient advocacy organizations.

Who You Are

You are a scientific and/or clinical professional with a passion for science and experience in the Rheumatology and/or Dermatology Disease area.  You have a marked curiosity about healthcare and business opportunities.  You keep patients, payers, and physicians top of mind in your daily work and collaborate to solve critical scientific and business challenges. You are willing to travel 30-40% of your time to engage with external stakeholders.

Qualifications

Required Skills

  • Advanced degree required: MD, PhD or PharmD.
  • Minimum 4 years of pharmaceutical industry experience, preferably with prior work in Headquarters-based Medical Affairs role &/or Field Medical based role.  Substitution of industry work with relevant clinical practice experience in Rheumatology/Dermatology may be considered.
  • Experience in Rheumatology and/or Dermatology preferred.
  • Experience and expertise in developing, communicating, and executing a comprehensive medical affairs plan.
  • Demonstrated the ability to build productive collaborations with medical experts.
  • Strong working knowledge of US and ex-US regulations as relevant to Medical Affairs.
  • Ability to travel 30-40%.

Preferred Skills

  • Experience with medical launch as well as products at different stages of the lifecycle
  • Demonstrated ability to effectively lead and collaborate with global, regional and/or affiliate medical to ensure regional activities are executed in alignment with global medical strategy and ensuring the insights and needs from them are known and properly addressed
  • Ability to manage projects and take initiative to solve complex and challenging problems

The base compensation range for this role is $158,700.00 - $264,600.00. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions. Must be able to support EST work hours.

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Biogen is hiring a Remote Senior National Account Manager, Federal Markets

Job Description

About the Role 

The Sr. National Account Manager (NAM), Federal Markets is responsible for developing and evolving the strategic operating plan for the Federal Accounts and managing the customer(s)' business. The candidate is accountable for securing profitable access for all BIIB products and serves as the single face of Biogen for their account (s). They are responsible for managing their customers' entire book of business. They need to have a deep understanding of their business model and growth strategies, establish broad, key executive relationships, and look for innovative ways to drive Biogen's business. 

The Sr. NAM, Federal Markets needs to direct large, stakeholder internal teams, inclusive of business leaders, to create strategies to optimize product revenue, ensure profitable access, maximize outcomes, and develop customer initiatives. The candidate is responsible for increased interactions with HQ leaders cross functionally, providing key customer insights, and reporting on customer, product, and innovation progress on an ongoing basis.

What You'll Do

  • Sr. NAM of Federal Markets will manage all business with: Department of Veterans Affairs, Department of Defense, TRICARE, Public Health Services, Indian Health clinical pathways
  • Ensure profitable access across all BUs, monitor and report on product profitability and performance
  • Development and oversee internal pull-through and push-through initiatives
  • Engage Biogen colleagues, as necessary, to support access and client relationships and resolve issues internally
  • Responsible for education, communication, and coordination with all segments of the business within their respective accounts and operate as "single point of contact"
  • Demonstrate the value of our products, services, to position Biogen as a leader in the industry
  • Develop strategic account plans and monitoring business progress toward achieving both short-term initiatives and long-term strategies
  • Share key customer insights and product trends to senior leadership, shaping current and future strategies
  • Direct franchise teams to achieve customer and product strategies and goals
  • Negotiate product contracts where applicable and monitor contract compliance
  • Participate in Business reviews across therapeutic areas as an SME on assigned accounts and a spokesperson for Market Access and Reimbursement.
  • Create reports, presentations for senior leadership on customer(s) performance and financial trends
  • Represent Biogen at key Federal Conferences and Congress (AMSUS, PVA. NAMCP)

Who You Are

A key member of the Market Access Team, that is responsible for leading the planning, development, and implementation of our market access strategy for existing and future products within the Federal Markets sector which includes (Department of Veterans Affairs (VA), Tricare/Department of Defense (DoD), Public Health Services (PHS), and Indian Health Services.)  This individual is a strong leader who builds coalitions and works across boundaries to achieve stellar results. Possess deep expertise in government healthcare programs, and managed markets space creating profitable access along with driving growth within existing portfolio. 

Qualifications

  • Minimum 7+ years pharmaceutical/biotech experience
  • Minimum of 4+ years’ experience in Federal Accounts with a preference of the candidate being a veteran
  • Strong presentation skills: ability to clearly convey his/her ideas to key internal partners
  • Strong relationships with national key stakeholders within the Government sector
  • Ability to lead within the matrix team, knows how to get things accomplished both through formal channels and the informal network
  • Strategic thinker: Understands the origin and reasoning behind key policies, practices, and procedures with the ability to interact with senior leaders and work across functional groups to build consensus
  • Demonstrated success in account management and understands the nuances and complexity of the Federal Government space
  • Candidates must have a valid driver’s license and an acceptable driving record according to Biogen policy to be considered
  • Travel 30%

Education: 
•    Bachelor’s Degree required, Master’s Level or above degree preferred. 

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Biogen is hiring a Remote Senior Business Analyst Commercial & Medical IT

Job Description

IT Business Analyst to be hybrid, based in our Warsaw office to provide guidance on solution options to address business problems and work with key business process owners to address these problems. The Business Analyst role is to fully understand the information and automation needs of the stakeholder community with whom they work. This understanding is the basis for their essential work which is to elicit, analyze, validate, specify and document the functional and business needs of stakeholders in the context of delivering IT services and solutions. The role of the business analyst covers a number of different areas and draws upon a variety of analytical skills. From simple understanding of the evolving the day-to-day needs of stakeholders, to creating functional needs breakdowns, to documenting current process flows, (and envisioning future process flows), building business cases, validating detailed designs with users and more; the role of the business analyst is critical to the success of IT in delivering appropriately tailored IT solutions for stakeholders. 

What You'll Do

  • Translate conceptual user requirements into functional requirements in a clear manner that is comprehensible to developers and the project team.
  • Communicate to project managers, sponsors, and other stakeholders throughout the project lifecycle changes and enhancements of business requirements so that issues and solutions are understood.
  • Collaborate with project sponsors to determine project vision and scope.
  • Conduct interviews to gather user requirements via workshops, questionnaires, surveys, site visits, workflow storyboards, use cases, scenarios, and other methods.
  • Work with stakeholders and project team to prioritize collected requirements.

Qualifications

Required Skills

  • University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines
  • 3+ years’ experience working as an IT professional managing projects Pharma-Biotech industry.
  • Experience working with business systems (i.e. Veeva CRM, Salesforce, MDM, reporting tools, etc.)
  • Must be self-motivated, team player, and well organized
  • Demonstrated successes in working with cross-functional resource teams
  • Ability to prioritize multiple assignments and/or tasks
  • Ability to work independently
  • Must be able to effectively communicate technical components of an initiative in both technical and business terms
  • Proven oral and written communication skills to a variety of audiences
  • Strong investigative, analytical and problem-solving skills 

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Biogen is hiring a Remote Biomarker Study Manager, Senior Manager

Job Description

About This Role

This role is responsible for clinical study bioanalytical and biomarker operations management. The bioanalytical and biomarkers study manger is a member of the clinical study team and will contribute to study start up, sample testing, data delivery and CRO management as it relates directly to supporting the PK, ADA and Biomarkers components of study, program and corporate timelines. This data is part of primary and secondary study endpoints and contributes to driving programs forward in the drug development process. The Biomarkers study manger reports to the Associate Director of study management within the Biomarkers department.

What You’ll Do

  • Represent Biomarkers and Bioanalytical functions on cross functional clinical study management teams
  • Lead operational support for collection and testing of clinical patient samples in support of clinical study protocols
  • Collaborate with multiple functional representatives to gather protocol input
  • Obtain contracts and work within the contracting process for execution of assay development, validation and sample testing needs
  • Meet with vendors regularly and oversee the completion of deliverables

Who You Are

You thrive in a fast-paced clinical development environment focused on bringing new therapies to patients. Your knowledge of scientific operations, GCLP and CRO management brings the ability to work within the both the internal teams and contracted lab environments.  

Qualifications

Required Skills 

  • Bachelor’s degree in a biological science or related technical field and 10+ years of industry experience
  • Experience working within GCP, GLP, & GCLP guidelines 
  • Good knowledge of phase I-III clinical study operations as it pertains to specialty testing (PK, ADA, Biomarkers)
  • Experience working with contracted central labs and biomarker/bioanalytical testing labs including sample management, data management, testing requirements and timelines
  • Experience reviewing clinical protocols and ICFs
  • Experience obtaining contracts and an understanding of Master Agreements and associated contracts

Preferred Skills

  • Basic understanding of biological assay methodologies, plate based, flow cytometry, genetic, etc.

 

The base compensation range for this role is $122k-$197k. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.  This person will support EST hours M-F 9am-5pm.

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Biogen is hiring a Remote IT Technical Writer - GxP environment

Job Description

The IT Technical Writer will work directly with IT System & Regulatory Compliance and IT professionals to assist in documenting deviations, corrective actions, system development lifecycle (SDLC) remediation, system assessments, and updating procedures.  In collaboration with IT professionals, this role will assist in articulating complex information for IT Quality, business process owners (BPO), system owners (SO), and subject matter experts (SME) review and approval.  A key component of this role is to guide SMEs in providing the necessary information to ensure the content is specific to its purpose and audience, and clearly articulated for future audit and compliance reviews.

What You'll Do

  • Documenting Root Cause Analysis (investigation details) and corrective actions for Deviations
  • Updating System Development Lifecycle documentation to their latest IT Quality approved templates
  • Creating and updating System Assessments for IT Applications
  • Writing Validation Plans and Reports to support project teams during new system implementations and upgrades
  • Updating Administrative Procedures to their latest IT Quality approved templates

Qualifications

  • 3+ years of relevant experience
  • GxP environment is a must have
  • Excellent written and verbal communication skills
  • Knowledge of IT computer system concepts
  • Ability to operate independently to deliver on assignments
  • Ability to interact independently with employees at all levels of the organization
  • Bachelor’s Degree
  • Fluent English

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Biogen is hiring a Remote Senior Manager, Marketing Automation (Salesforce Cloud)

Job Description

About this role:

The Senior Manager, Techno-Functional Analyst Marketing Automation will enable business stakeholders globally to establish and run customer engagement plans, optimize automated customer journeys, and create/launch personalized targeted marketing campaigns across relevant channels. The role is an expert on the functionality of marketing automation tools, in particular automation through Salesforce Marketing Cloud (SFMC). The individual works closely with various teams and stakeholders on local and global levels to understand the business process, define functional requirements, and design appropriate capability solutions. Further, the role runs the implementation process and manages testing, to ensure marketing automation capabilities that enable relevant customer solutions.

What you will do:

Ownership of key digital market automation capabilities that fit within the digital capabilities ecosystem and can perform and scale at high quality across the regions, including management of daily tasks, priorities, and road maps. Implement capability configurations, applying best practices relative to the application and/or its integration, to optimize the capability in terms of meeting stakeholder needs.

Work with business stakeholders to define business requirements and translate them into specifications for customized configurations and/or development, taking system requirements and limitations into account. Collaborate with various internal and external stakeholders for planning, development, integration, implementation, and testing of capabilities.

Define relevant performance KPIs for the marketing automation capabilities and monitor the performance to identify optimization opportunities.

Perform comprehensive testing of the marketing automation capabilities to ensure that solutions function as intended, avoid unintended behaviour, and identify opportunities for optimization.

Coordinate with stakeholders across cross-functional technical teams to achieve the intended and aligned outcomes.

Qualifications

  • BA or Master’s degree, or equivalent experience
  • Fluent in English
  • Certified manager of Salesforce Marketing Cloud
  • 5+ years of proven relevant work experience and a minimum of three years of previous experience with automating digital engagements, including requirements definition and management.
  • A deep understanding and proven track record of designing, planning, and delivering multichannel and digital engagement journeys through SFMC, including system design and analysis experience.
  • Operational knowledge covering email development and deployment, marketing automation, channel consent and preference management, mobile marketing, paid search, SEO, and understanding of channel orchestration in omnichannel campaigns.
  • Record of user experience design, process analysis, functional testing, and regression testing to implement functional solutions.
  • Strong experience in stakeholder management to gather requirements for technical specifications.

Other job requirements:

  • Experience with vendor and external business partner management
  • Understanding of Life Sciences commercial model
  • Excellent written, oral, presentation and communication skills in English
  • Experience with agile methodology
  • Ability to manage multiple tasks, good project management skills.
  • Ability to work from strategy to execution.
  • Direct approach and positive attitude
  • Experience working in a matrix structure and collaborating with teams both cross-functionally and across geographies.
  • Problem-solving and critical thinking skills

Tools & Solutions:

  • Excellent, certified expertise in Salesforce Marketing Cloud
  • Experience with Veeva CRM, OneTrust, Akamai, API integrations
  • A plus: SQL (particularly on salesforce platform)

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Biogen is hiring a Remote Principal, Application Specialist- SailPoint

Job Description

About This Role  
Biogen is seeking an experienced Application Specialist who has expertise in designing, programming, implementing and maintaining SailPoint IdentityNow. This role includes providing advanced training, super-user guidance, and L3 support of the application particularly as it relates to its usage. You are the ultimate power user who knows the ins and outs of the app and are often charged with figuring out how to get a particular job done and are always at the forefront in new functional implementations. Responsible for end-to-end service delivery to ensure projects, enhancements and L3 support is provided with best-in-class quality. You will work with cross-functional teams of business analysts, technical architects, process teams and project managers to deliver a variety of upgrades, enhancements, new modules and other systems development initiatives. This lead will report directly to the Head of Access Automation within our Cybersecurity organization and have functional responsibilities into Enterprise Architecture as an Enterprise Application Owner.  Access Automation is a cornerstone of Biogen’s application security and GXP/Quality compliance programs.   

What You’ll Do

  • Troubleshoot challenging reported application issues
  • Testing new applications and new application versions, and recommending enhancements
  • Responsible for maintaining the optimal performance of applications and performing  multiple diagnostic tests before applications are released  
  • Supports current and new users with application training
  • Working with applications in accordance with business needs
  • Develop, rollout and support business and application services that meet ongoing and evolving user needs
  • Oversee the delivery of all configuration, development and management activities related to a given set of application services 
  • Lead the hands-on design, development and integration of our next generation Access Automation solution 
     

Qualifications

Who You Are 
You are resourceful and driven IT professional who has a track record of delivering superior customer experience. You have demonstrable experience troubleshooting complex processes, finding the root cause and driving continuous improvement.  You can adapt to different stakeholders’ technical abilities and communicate effectively with business and IT professionals.  

Required Skills  

  • 5+ years of IT experience, including 3 years of SailPoint application administration or service delivery 
  • Undergraduate degree or the equivalent combination of education and experience 
  • Knowledge across Identity Governance Administration (IGA) platforms (SailPoint), Identity Assurance platforms (MS Active Directory, Azure, Okta) and PAM platforms (CyberArk). 
  • User Support  
  • Application Support  
  • Change Management/Control 
  • Agile Methodology 

Preferred Skills

  • SailPoint IDN certification(s) e.g. SailPoint Certified IdentityNow Professional, SailPoint Certified IdentityNow Engineer 
  • Contract Management 
  • SLA Management 
  • Vendor Management 

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Biogen is hiring a Remote Customs Valuation , Trade Compliance Manager

Job Description

About This Role 

The purpose of this role is to strengthen and operate Biogen’s Customs Valuation and Contracts Governance Center of Excellence by developing scalable processes and systems, implementing best practices across business units, and maintaining internal controls to reduce risks.

What you will do

  • Develop and implement procedures as well as repository mechanisms for Customs valuation methodologies, determining appropriate customs valuation including statutory additions (Royalties, Commissions, management, service fees, etc.) across Biogen’s portfolio.
  • Perform Customs Valuation periodic audits in key geographies, document areas of improvement, design, and lead execution of corrective actions to maintain compliance standards. Expand continuous improvement practices and innovation strategies to streamline customs valuation processes.
  • Closely partner with Finance, Tax and Accounting functions to proactively identify potential changes to customs valuation and implement applicable adjustments with stakeholders. Represent GTC in global initiatives to provide customs valuation subject matter expertise.
  • Manage operational activities for multiple countries as needed (e.g., Europe, ANZ, etc.)
  • Partner cross-functionally on projects related to international trade activities, e.g. product launches, contracts, new business/partner set up.

Qualifications

Who You Are

You have strong analytical and project management skills and experience developing Customs Valuation Analysis, for commercial and not commercial products. You also have experience working across functions (e.g. Tax, Finance, Accounting) on transfer price adjustments and customs valuation topics. You have proven experience working in a diverse global team with resources based across multiple countries and are able to work independently with internal stakeholders across all levels in the organization.

Required skills

  • Minimum 5 years of direct experience working with Customs Valuation and complex trade compliance valuation topics (e.g., Royalties, First sale, 6 valuation methodologies, etc.) in multinational companies.
  • Strong understanding of the relationship of Transfer pricing and Customs Value
  • Extensive experience in Customs Compliance gained in Life Science Industry or other regulated industries.
  • Experience with setups in matrix organizations and complex supply chains
  • Extensive experience and knowledge of trade compliance fundamentals for  contracts' due diligence
  • Good understanding of international trade regulations and requirements in Europe and/or APAC

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Biogen is hiring a Remote Field Excellence Lead, Rare Disease

Job Description

About This Role 
Field Excellence Lead supports flawless execution against the strategic objectives of customer facing commercial field teams. This role reports to Head of Field Excellence & Learning and collaborates with the business unit to optimize, represent, and enable commercial field-based employees. The key goal of this position is to readily translate and connect HQ to the field and back to drive a high standard of execution in a dynamic environment, while also enabling agile decision-making.
  
What You’ll Do 
•    Align field team with business unit strategic objectives through operational initiatives, leadership reporting and executional expectation setting
•    Understand adoption of HQ strategy to help the business unit and field leaders be more effective and prioritize the workstreams and operational tools that will have the largest potential impact
•    Gatekeeper for HQ communication to field teams to ensure appropriate visibility for key brand, compliance, and home-office messages and maximize time spent with customers
•    Collaborate with incentive compensation (IC) team to align business unit strategy and Incentive Compensation 
•    Represent and appropriately prioritize the needs of the business unit to internal operations and data teams
•    Support and strengthen inter-company operational relationships

Who You Are 
You are driven to execute with high quality, and you communicate effectively to help field teams execute at their best. You enjoy being involved in what is happening and rolling up your sleeves to see a project succeed. You’re able to confidently present your ideas to leadership because you listen and get feedback from stakeholders in all relevant roles and at all levels.

Qualifications

Required Skills
•    5+ years Commercial experience (Marketing and/or Operations)
•    Operational experience working with a large number of stakeholders on firm deadlines
•    Commercial biotech/pharma experience
•    Executive presence with experience presenting to VP+ stakeholders
•    Detail oriented with a history of bringing projects to completion
•    Bachelor’s Degree; Advanced Degree preferred

Preferred Skills
•    Field sales experience
•    MBA or entrepreneurial experience
•    Excel fluency

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Biogen is hiring a Remote HR Solution Partner (12 months fixed term contract)

Job Description

The HR Solution Partner responsibilities include:

  • Process Optimization:
    • Identify opportunities to streamline HR processes, improve data accuracy, and enhance overall efficiency in collaboration with HR stakeholders.
    • Lead initiatives to digitize and automate HR workflows, reducing manual efforts and enhancing user experience.
    • Driving user-centric solutions, understanding journeys and experiences and centralize and maintain the documentation of process maps, journeys, and playbooks.
  • Aligning HR Platforms Management with business capabilities:
    • Driving the implementation, configuration, and maintenance of HCM, ATS and LMS to streamline HR processes.
    • Collaborate with IT and vendors to ensure the integration of HR Platforms, Product releases, resolving technical issues and enhancing system capabilities.
    • Drive Platform innovation to meet business capabilities.
  • Data Governance and Analytics:
    • Establish and maintain data governance standards, ensuring data integrity, security, and compliance with regulatory requirements.
    • Utilize HR analytics team to provide insights that support strategic decision-making and enhance workforce planning.
  • User Testing, Training and Support:
    • Develop and deliver training programs for HR users to ensure effective utilization of HR Platforms.
    • Provide ongoing support to HR teams and end-users, troubleshooting issues and implementing solutions in a timely manner.
  • Change Management:
    • Lead change management initiatives related to HR technology implementations, ensuring smooth transitions and user adoption.
    • Engage with HR stakeholders to communicate system updates, changes, and best practices

Qualifications

  • Exposure to Program and/or Project Management
  • Analytical skills and ability to identify trends 
  • Skilled at Business Partnership, Advising, & Consulting 
  • Excellent Interpersonal & Communication Skills 
  • 3-5 years of experience in human resources or related work
  • Understanding of one HR-related technologies.
  • A BS/BA degree is required. Advanced degree preferred (e.g., MBA).  

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Biogen is hiring a Remote Senior Manager, Regulatory CMC Lead

Job Description

About This Role 
This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific antisense oligonucleotide projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated. Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early-stage development programs or working with the Regulatory CMC Lead for late-stage development or commercial programs.  The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities associated with the program and will report to the Regulatory CMC Antisense Oligonucleotide Team Lead.  

What You’ll Do

  • Providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives
  • Preparation and delivery of CMC Regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (including IND/IMPD/CTAs/MAAs)
  • Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities.
  • Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions
  • Managing CMC aspects of routine and non-routine Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
  • Monitoring changes in the Regulatory CMC environment to support and advise key stakeholders and teams
  • Providing input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy
  • Coordinating and completing regulatory assessments of CMC changes in the designated systems
  • Responsible for assuming responsibilities from the Team Lead or Global Regulatory CMC lead, as agreed and delegated and maintaining open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions
  • Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of Regulatory CMC on cross functional work streams
  • Responsible for leading or assisting in delivery of Regulatory CMC initiatives and the development of Regulatory CMC standards and SOPs, as assigned
  • Ensure that appropriate records are maintained in the designated system for submission in assigned regions

Key Contacts and Interactions: Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels.

Customer focused: Interacts with a functional area key stakeholder both internally and externally, including subject matter experts, partners and regulatory agency personnel

Qualifications

Who You Are
You love working in a team environment and have a customer-focused mindset. You have experience working in the life sciences industry within a Regulatory CMC role. You have a track record of approaching work with a strategic vision and highly effective in project leadership as well as working with regulatory agencies and other key stakeholders.

Required Skills

Regulatory Skills

  • At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
  • Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products (biological, oligonucleotide, and/or chemical entities)
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products
  • Experience of direct communication and negotiation with regulatory agencies on CMC matters
  • Knowledge of GMP requirements and standard systems (e.g. change management systems)
  • Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure

Leadership/Management Skills

  • Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones.
  • Ability to influence cross-functional stakeholders to ensure execution of optimal RegCMC strategy
  • Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
  • Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
  • Demonstrated competency in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
  • Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.
  • Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.

Preferred/Additional: Recognized experience in project and timeline management.  Experience with clinical development and associated Regulatory CMC submissions. Previous oligonucleotide experience (desired but not essential).

Education:Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or relevant pharmaceutical science field; Graduate degree preferred.

   

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Biogen is hiring a Remote Associate Director, Biostatistics

Job Description

The Associate Director of Biostatistics is responsible for leading complex or integrated study design and data analysis in clinical development. He/She act as RDPT Biostatistician, to ensure valid and efficient study designs that allow clearly interpretable results, and timely delivery of analyses, reports and regulatory documents with high quality. He/she builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework.  He/She provides responses to statistical issues arising in regulatory, other legal settings, or external development partners. He/She provides mentorship to new/junior biostatisticians. He/She also contributes to the long-term growth strategy of the department by participating in process improvement initiatives and keeping up to date of and contributes to the current statistical methodology development. 

Principal Accountabilities

  1. Key player in the strategic planning and execution of the clinical development plan for the assigned project; provides strategic contributions to the clinical studies in the program, including study designs, protocol development, statistical analysis plans, data analysis and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including INDs, BLAs, NDAs and MAAs.
  2. Manages assigned staff and FSPs statisticians to ensure quality and consistency of the deliverables; provides guidance and support to facilitate their development and enhanced efficiency; provides regular feedback to staff and management. 
  3. Provides key strategic contributions in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings or meetings with KOLs as required.
  4. Serves as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel (protocols, CSRs, regulatory documents, and manuscripts), and acts as an internal consultant as assigned on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
  5. Participates in approved process improvement initiatives; keeps up to date on current statistical methodology development and regulatory environment

Qualifications

Who You Are: 

You are an experienced biostatistician with a thorough understanding of statistical principles and clinical trial design/methods and with experience in submission or responding to regulatory questions and with proven ability to develop creative statistical/technical/regulatory acceptable solutions to complex problems in the design/analyses of clinical trials.  You have leadership skills in effective communication, proactive strategy thinking, priority evaluations, and team working. 

  • PhD in Biostatistics/Statistics or equivalent with a preferred 6+ years relevant work experience or MS in Biostatistics/Statistics with a preferred  8+  years relevant experience
  • Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
  • Ability to develop innovative/creative statistical/technical solutions to complex problems.
  • Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
  • Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.
  • Strong verbal and written communication skills.
  • Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership.
  • Submission experience with BLA or NDA

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Biogen is hiring a Remote Principal, Application Specialist- Access Automation (Access Services)

Job Description

About This Role  
Biogen is seeking an experienced Application Specialist who has expertise in designing, programming, implementing and maintaining SailPoint IdentityNow. This role includes providing advanced training, super-user guidance, and L3 support of the application particularly as it relates to its usage. You are the ultimate power user who knows the ins and outs of the app and are often charged with figuring out how to get a particular job done and are always at the forefront in new functional implementations. Responsible for end-to-end service delivery to ensure projects, enhancements and L3 support is provided with best-in-class quality. You will work with cross-functional teams of business analysts, technical architects, process teams and project managers to deliver a variety of upgrades, enhancements, new modules and other systems development initiatives. This lead will report directly to the Head of Access Automation within our Cybersecurity organization and have functional responsibilities into Enterprise Architecture as an Enterprise Application Owner.  Access Automation is a cornerstone of Biogen’s application security and GXP/Quality compliance programs.   

What You’ll Do

  • Troubleshoot challenging reported application issues
  • Testing new applications and new application versions, and recommending enhancements
  • Responsible for maintaining the optimal performance of applications and performing  multiple diagnostic tests before applications are released  
  • Supports current and new users with application training
  • Working with applications in accordance with business needs
  • Develop, rollout and support business and application services that meet ongoing and evolving user needs
  • Oversee the delivery of all configuration, development and management activities related to a given set of application services 
  • Lead the hands-on design, development and integration of our next generation Access Automation solution 
     

Qualifications

Who You Are 
You are resourceful and driven IT professional who has a track record of delivering superior customer experience. You have demonstrable experience troubleshooting complex processes, finding the root cause and driving continuous improvement.  You can adapt to different stakeholders’ technical abilities and communicate effectively with business and IT professionals.  

Required Skills  

  • 5+ years of IT experience, including 3 years of SailPoint application administration or service delivery 
  • Undergraduate degree or the equivalent combination of education and experience 
  • Knowledge across Identity Governance Administration (IGA) platforms (SailPoint), Identity Assurance platforms (MS Active Directory, Azure, Okta) and PAM platforms (CyberArk). 
  • User Support  
  • Application Support  
  • Change Management/Control 
  • Agile Methodology 

Preferred Skills

  • SailPoint IDN certification(s) e.g. SailPoint Certified IdentityNow Professional, SailPoint Certified IdentityNow Engineer 
  • Contract Management 
  • SLA Management 
  • Vendor Management 

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Biogen is hiring a Remote Sr. Medical Science Liaison, Specialty Care and Evidence Generation- Georgia, Florida, Puerto Rico

Job Description

About this role

The Senior Medical Science Liaison (MSL) role is a part of US Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. The Senior Medical Science Liaison (MSL) enables critical stakeholder engagement with Key Medical Experts (KMEs) and other healthcare professionals (HCPs) so they understand the clinical and scientific narrative for Biogen’s therapies. Biogen’s priority is to continue to foster and enable a diverse and inclusive workforce – representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities – that reflects the communities where we operate and the patients who we serve.

What You Will Do

  • Be a credible medical/ scientific expert who engages with KME and HCP to increase confidence in making the best clinical decisions pertaining to disease state and Biogen’s products in the near and long term for the benefit of patient care.
  • Focus on building deep, strategic, long-term relationships with internal & external stakeholder to be viewed as a partner rather than transactional.
  • Be a “partner in the trenches”—be responsive, engage often and be a solutions-driven conduit to leaders in the medical community.
  • Engage in projects and/or initiatives aligned to US Medical strategy, objectives and tactics
  • Be highly accountable to qualitative and quantitative medical excellence performance goals, standards, and measurements.Deliver against KME engagement plans that add high value by navigating resources at the office in collaboration with field and non-field colleagues.  Capture and report KME/HCP medical insights using Veeva with the highest level of consistency and accuracy to help inform the medical and clinical strategies.

Who You Are

You are a scientific or clinical professional with a passion for science and deep scientific knowledge.  You have a marked curiosity about healthcare and business opportunities.  You keep patients, payers and physicians top of mind in your daily work and collaborate to solve critical scientific and business challenges.

Qualifications

Required skills

  • Advanced Scientific or Clinical degree; doctoral (MD, PhD, PharmD) level preferred
  • Experience in Neurology
  • Minimum 5 years’ experience as a Medical Science Liaison or similar role within the pharmaceutical/biotechnology industry
  • Bilingual in English / Spanish
  • Must reside in Florida or Georgia
  • Effective communication: Communicates concisely, confidently, and credibly; Easily understands other points of views and responds appropriately; Listens with empathy to respond to current and future needs and adjust the communication according to the audience.
  • Digital potential: Comfortable using and experimenting with technology; Embraces and optimally utilizes new tools and systems; Demonstrates a willingness and aptitude to learn if not yet well versed.
  • Accountability: Delivers reliably against goals; Motivated to perform to meet and even exceed metrics and Key Performance Indicators (KPIs). Views metrics and KPIs as a positive opportunity to communicate value to internal stakeholders.
  • Ethical: Understands rules for industry and is committed to following them for the benefit of patients.
  • Able to travelat least 60% of the time, including ability to travel overnight and occasionally on weekends once, assuming health concerns (such as COVID-19) are no longer a factor.
  • Must be 18 years of age or older with valid driver’s license and an acceptable driving record. Must have authorization and ability to drive a company leased vehicle or rental.

Preferred Skills & Therapeutic Area Specific Skills

  • Clinical experience and subject matter expertise in the respective therapeutic area is optimal

#LTD-1

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Biogen is hiring a Remote Sr. Medical Science Liaison, Specialty Care and Evidence Generation- Florida and Puerto Rico

Job Description

About this role

The Senior Medical Science Liaison (MSL) role is a part of US Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. The Senior Medical Science Liaison (MSL) enables critical stakeholder engagement with Key Medical Experts (KMEs) and other healthcare professionals (HCPs) so they understand the clinical and scientific narrative for Biogen’s therapies. Biogen’s priority is to continue to foster and enable a diverse and inclusive workforce – representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities – that reflects the communities where we operate and the patients who we serve.

What You Will Do

  • Be a credible medical/ scientific expert who engages with KME and HCP to increase confidence in making the best clinical decisions pertaining to disease state and Biogen’s products in the near and long term for the benefit of patient care.
  • Focus on building deep, strategic, long-term relationships with internal & external stakeholder to be viewed as a partner rather than transactional.
  • Be a “partner in the trenches”—be responsive, engage often and be a solutions-driven conduit to leaders in the medical community.
  • Engage in projects and/or initiatives aligned to US Medical strategy, objectives and tactics
  • Be highly accountable to qualitative and quantitative medical excellence performance goals, standards, and measurements.Deliver against KME engagement plans that add high value by navigating resources at the office in collaboration with field and non-field colleagues.  Capture and report KME/HCP medical insights using Veeva with the highest level of consistency and accuracy to help inform the medical and clinical strategies.

Who You Are

You are a scientific or clinical professional with a passion for science and deep scientific knowledge.  You have a marked curiosity about healthcare and business opportunities.  You keep patients, payers and physicians top of mind in your daily work and collaborate to solve critical scientific and business challenges.

Qualifications

Required skills

  • Advanced Scientific or Clinical degree; doctoral (MD, PhD, PharmD) level preferred
  • Minimum 5 years’ experience as a Medical Science Liaison or similar role within the pharmaceutical/biotechnology industry
  • Effective communication: Communicates concisely, confidently, and credibly; Easily understands other points of views and responds appropriately; Listens with empathy to respond to current and future needs and adjust the communication according to the audience.
  • Digital potential: Comfortable using and experimenting with technology; Embraces and optimally utilizes new tools and systems; Demonstrates a willingness and aptitude to learn if not yet well versed.
  • Accountability: Delivers reliably against goals; Motivated to perform to meet and even exceed metrics and Key Performance Indicators (KPIs). Views metrics and KPIs as a positive opportunity to communicate value to internal stakeholders.
  • Ethical: Understands rules for industry and is committed to following them for the benefit of patients.
  • Able to travelat least 60% of the time, including ability to travel overnight and occasionally on weekends once, assuming health concerns (such as COVID-19) are no longer a factor.
  • Must be 18 years of age or older with valid driver’s license and an acceptable driving record. Must have authorization and ability to drive a company leased vehicle or rental.

Preferred Skills & Therapeutic Area Specific Skills

  • Clinical experience and subject matter expertise in the respective therapeutic area is optimal
  • Bilingual is a plus

#LTD-1

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Biogen is hiring a Remote Associate Director, Pharmacometrics

Job Description

About This Role:

Pharmacometric analyses and insight are critical in the development of drug candidates, determination of product viability, and maximization of commercial value at Biogen. The Associate Director, Pharmacometrics has responsibility for high priority clinical development assets providing guidance on and executing advanced modeling strategies. He/she contributes to the Pharmacometrics group strategy across disease areas being a respected and visible leader on Pharmacometric issues for program teams and across the functional organization. This Role reports to the Head of Pharmacometrics. The Associate Director, Pharmacometrics collaborates closely with Clinical Pharmacology advising and mentoring on advanced pharmacology models.

 

What You’ll Do:

· Providing guidance on and executing advanced modeling strategies, especially population PKPD analyses and simulation

· Leading and executing complex pharmacometric activities on high priority program teams

· Contributing and providing Pharmacometric expertise to regulatory strategy and activities within the function and companywide

· Contributing and providing Pharmacometric expertise to program development teams strategy and activities

· Mentoring Clinical Pharmacology and Pharmacometric staff on population analysis methodology

· Promoting the importance and benefits of pharmacometrics analyses companywide

· Publishing in scientific journals and presenting at internal and external scientific events

 

Who You Are:

You are a PhD level scientist from a quantitative background with 5+ years of experience in population PKPD analysis methodology in an industrial or academic setting. You enjoy working in a multidisciplinary environment, providing strategic insight, presenting your work and mentoring colleagues on your areas of expertise.

Qualifications

Required Skills:

· PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or other suitable related fields with 5+ years of relevant industry experience

· Deep and extensive experience with advanced population PKPD methodology

· Deep understanding of the Clinical Pharmacology principles and methodologies

· Deep understanding of the drug development process and regulatory guidance

· Ability to interpret quantitative results and extract knowledge from data and outcomes

· Attention to detail, writing and communication

· Ability to mentor and train people

· Excellent interpersonal, presentation and communicating skills

· Software skills: Experience with the use of PK/PD software packages such as NONMEM, Monolix, and R

 

#LTD-1

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