Description

• Degree of Medicine ( MBBS mandatory)
• Board certification/equivalent in Internal Medicine/General Medicine area is strongly preferred.
• Clinical/Clinical Research experience is strongly preferred.
• 5 or more years’ experience of working in a medical or safety department
• Previous experience of working in a CRO environment at least 3 years is strongly preferred. 
• Demonstrable expert knowledge of medical terminology and detailed knowledge of medical monitoring processes and regulations and expert experience with medical data review.Working knowledge of FDA Guidance Documents / EU Directives / drug / device development, and clinical monitoring procedures
• Knowledge of web-based communication tools for conferences.

Description

Premier Research is looking for an Executive Director, Program Stategyto join ourDermatology team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech^SM.Join us and build your future here.

As the Executive Director, Program Strategy, you’ll have the opportunity to showcase your strategic and therapeutic expertise to advise, consult, plan and direct the design and strategy of new business opportunities and provide consultative services to customers. You’ll also support the Business Development and Operations efforts for key customers as a Principal Strategist in the design and management of clinical trials/programs bringing specific regulatory, medical/scientific and operational knowledge in Rare Diseases and Pediatrics. You will also provide support and input as it relates to the RFP process and offer support to operational teams for strategy, risk assessment and management, study design challenges and overall customer relations.

What you’ll be doing:

• Strategize with Business Development for all proposal development support related to Rare Diseases and Pediatric studies; lead and partner with Operations and Business Development for planning of bid defense and capability meetings. Liaise with Clinical Trial Management (CTM) colleagues globally to ensure continuity throughout assigned global RFPs and Business Development opportunities
• Review RFP’s, assess monitoring strategies and resources to support budget development
• Develop and improve the pricing and related strategies that provide the best scenario to meeting project margins on successfully awarded work
• Provide leadership to professional staff and managers within the Rare Disease and Pediatrics team
• Ensure compliant and profitable project delivery that meets or exceeds customer and industry standards
• Assist with improvements to the standard capabilities and selling tools required
• Support our Medical Writing Team in the development of protocol design as well as CSR review and provide input
• Develop and foster relationships with existing and potential clients as well as the Premier site relationships and networks aligned with Rare Diseases and Pediatrics
• Assist with feasibility assessments and provide input for feasibility questionnaires and may also directly connect with potential sites for assessment of participation, protocol considerations and enrollment projections
• Maintain strong knowledge of major events and challenges within the Rare Diseases and Pediatrics area and provide instruction to team members and managers on those issues as well as training

What We're Looking For: 

• Bachelor's degree (PhD or MS strongly preferred) in a clinical, science or health related field along with 10-12 years in Clinical Trials Experience including 5 years in a CRO or pharmaceutical environment.
• Experience in designing and/or managing clinical trials in Rare Diseases and Pediatrics, which includes Gene/Cell Therapy Clinical Research including strong knowledge of regulatory, scientific, technical, and clinical operations; extensive knowledge of the commercial and regulatory environments in the area of Rare Diseases and Pediatrics, including gene/cell therapies.
• 7-10 years in a leadership/coaching position with the ability to guide others through major changes, encourage teamwork and develop team capabilities
• In depth experience in public speaking and presentation delivery
• Excellent verbal and written communications skills with an ability to distill scientific or medical concepts into compelling and differentiating strategies and arguments
• Professional and interpersonal skills with the energy, vision and drive to succeed in a high performance culture
• Able to motivate and manage a number of stakeholders and contributors to meet deadlines and to produce a winning service proposal and high quality work
• Must be available to perform up to 50-65% of overnight business travel, both domestic and international.

Why choose Premier? 

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and most importantly about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Description

Premier Research is looking for a part-time, Clinical Research Sub-Investigator, Contractor to join our MedTech, Pediatrics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.  

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.  
• We are Built by You. Your ideas influence the way we work, and your voice matters here.  
• We are Built with You. As an essential part of our team, you help us deliver medical innovation that patients are desperate for.  

Together, we are Built for BiotechSM. Join us and build your future here.  

What you'll be doing: 

• Serves as the Sub-Investigator for the clinical research trial, adhering to the IRB-approved research protocol and GCP ICH guidelines. 
• Comfortable with a decentralized (also known as a direct-to-subject or site-less) clinical research trials in which all study visits, including subject consent, inclusion/exclusion criteria, and ad-hoc subject visits will be performed through Telehealth video conferencing. 
• Provides study activity/task oversight and medical expertise/medical support including feasibility, clinical protocol design, medical training and medical review of data collection forms.
• Perform routine records review to ensure patient safety and data integrity.

What we are searching for: 

• Medical Doctor or DO, Nurse Practitioner or Physician Assistant from US accredited institution. 
• 1-3 years Sub Investigator experience preferred.
• Working knowledge of GCP, ICH, and Human Research Subjects Protection guidelines, as well as regulatory requirements relating to clinical development and safety compliance with ethical, legal and regulatory standards preferred.
• Publications and clinical information presentation experience.

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

#LI-TW1  

Description

Premier Research is looking for a Clinical Lead II to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech^SM. Join us and build your future here.

What you'll be doing:

• Driving and managing the clinical components of the Start up process from site ID to qualification and site activation.
• Training and management of the CRA team for the lifecycle of project, including: Monitoring visit forecasting/resource management; Adherence to the protocol, SOPs/regulations and project plans; Ensuring data quality and patient safety
• Creates and maintains, in a timely fashion, study specific clinical monitoring plans (CMP) utilizing approved templates ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
• Ensures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues
• Plans and drives both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestones
• Apply a risk-based quality management mindset in order to proactively mitigate issues and also provide support for study audits and responses

What we are searching for:

• Bachelor's degree, or local equivalent, in a clinical, biological, scientific, or health-related field
• 5-7 years of clinical research/monitoring experience is preferred
• 1-2 years of previous Clinical Oversight experience (clinical trial manager) within a Clinical Research Organization

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

#LI-CI1

Description

We’re looking for a Senior Project Manager to join our Neuroscience team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success. This is a permanent role to be located in Europe, in the country, where we have our entity. 
 

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech^SM. Join us and build your future here.

What you’ll be doing:

• Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
• Adherence to project budget and scope of work to realize project profitability
• All project tasks completion in accordance with project plans and in compliance with global and consistent Premier Research processes, policies, and procedures
• Project risks identification and mitigation
• Effective communication, and project status reports and monthly progress reports are provided both internally and externally
• Compliance for project-related training
• Adequate resourcing to meet project deliverables and milestones
• Representation at client meetings along with commercial colleagues to help win new business

You’ll need this to be considered:

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education 
• Demonstrated clinical research experience
• Strong global project management experience, preferably with a CRO
• Neuroscience experience is essential
• Experience in managing a study from start to completion, managing multiple phases, and managing the full project life cycle
• Budget/finance/costing experience on a project level
• A highly confident and effective presenter, fluent in English with strong oral and written communication 
• Willingness to travel

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. 

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

#LI-KP1

Description

Premier Consulting, a division of Premier Research, is seeking a Principal Medical Writer. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.

What you’ll be doing:

• Lead a group of writers assigned to a project, manage the greater project, and assign tasks to project team writers
• Act as lead writer; contributes to clinical and regulatory document creation, review the work of projects writers
• Act as principal liaison to project stakeholders
• Work with regulatory strategist(s) and other stakeholders to create submission strategies, timelines, for regulatory submissions (e.g. meeting packages, Investigational New Drug [INDs] applications, and sections of marketing applications [NDA/BLA/MAA])
• Creates clinical and regulatory documents according to ICH guidance
• Ensure timeline adherence of project writers and self, provide project status updates on a regular basis to stakeholders, leads and managers

What we’re searching for:

• Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred 
• 10+ years of medical writing experience in a pharmaceutical company or a contract research organization
• Maintains current knowledge of ICH and local regulatory authority drug research and development regulations 
• Experience mentoring and training staff
• Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and relevant regulatory‑writing style

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly
care about one another, about our clients, and about our mission of furthering
research to improve the lives of patients in critical need.

• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.

• Our dedication to biotech and specialty pharma is unlike any other. We provide our
staff with innovative technologies and continuous learning opportunities so that they
have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse
population, we require the perspectives of a diverse staff thinking creatively, challenging ideas,
and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion,
and empowerment, we create a community of belonging that welcomes differences, fuels
innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are
excited about this role, but your past experiences do not perfectly align with the position as
described, we encourage you to apply anyway. You may be exactly the right candidate for this
role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal
guidelines. All qualified applicants will receive equitable consideration without regard to race,
color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

#LI-CI1

Description

Premier Consulting, a division of Premier Research, is seeking a Senior Medical Writer. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.

What you’ll be doing:

• Independently write and format clinical and regulatory documents 
• Review and approve clinical and regulatory documents including, but not limited to: synopses and protocols, clinical study reports, in-text tables, appendices, addendums, study plan outlines, and documents for regulatory submissions (e.g., Investigational New Drug applications, sections of marketing applications, investigator brochures, or other clinical and regulatory documents) 
• Ensure timeline adherence for each assigned project, provide project status updates on a regular basis and carry out contractual obligations for each assigned project 
• Work on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and clients  
• Interpret and summarize clinical data as needed to prepare documents 
• Review all source documents, perform literature searches, and interact with internal team members and external clients to develop a thorough understanding of project background, timelines, and goals 
• Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents

What we’re searching for:

• Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred 
• ​BA/BS and 6-10 years of experience in medical/regulatory writing; or MS and 4-6 years of experience in medical/regulatory writing; or PhD and 2+ years of experience in medical/regulatory writing 
• ​International experience desirable 
• Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation 
• ​Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets 
• Ability to learn fast, to convert relevant scientific data/information into high quality summaries and reports

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly
care about one another, about our clients, and about our mission of furthering
research to improve the lives of patients in critical need.

• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.

• Our dedication to biotech and specialty pharma is unlike any other. We provide our
staff with innovative technologies and continuous learning opportunities so that they
have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse
population, we require the perspectives of a diverse staff thinking creatively, challenging ideas,
and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion,
and empowerment, we create a community of belonging that welcomes differences, fuels
innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are
excited about this role, but your past experiences do not perfectly align with the position as
described, we encourage you to apply anyway. You may be exactly the right candidate for this
role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal
guidelines. All qualified applicants will receive equitable consideration without regard to race,
color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

#LI-CI1

Description

Premier Research is looking for aSite Start Up Associate/Senior Site Start-Up Associateto join ourStudy Start-Upteam in Korea! You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

•       We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

•       We are Built by You. Your ideas influence the way we work, and your voice matters here.

•       We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech^SM. Join us and build your future here.

What you'll be doing:

• Prepare and submit Local IRB Applications, RA Applications, and other local regulatory authorities or hospital approval submissions; prepare ongoing submissions, amendments, and periodic notifications required by central and local EC and RA; submit end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities.
• Perform essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with local regulatory requirements and ICH/GCP guidelines.
• Investigator Contract and budget negotiator - produce site contracts and submit proposed contract and budget for site; negotiate budget and contract with site and via Contracts Lead with Sponsor.
• Provide all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up; ensure accuracy and completeness of trial master file documents submitted during start-up and perform QC review before transfer to Maintenance for filing in TMF.
• Liaise with internal team members to review areas that impact study start-up and share start-up information with the project team.
• Provide country-level intelligence on site start-up and ensure that regulatory intelligence is maintained on the central repository; maintain a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.
• Support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
• Review and advise on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements; provide training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.

You'll need this background to be considered: 

• Undergraduate degree in a clinical, science, or health related field and or 3 years’ experience in the submission of clinical trial applications.
• Knowledge of the relevant country specific regulatory requirements for conducting clinical trials
• Knowledge of site and institution specific contract requirements
• 3+ years of experience in the clinical trial submissions
• Proven proficiency in the development and review of Informed Consent Form templates
• Strong verbal and written communication and negotiation skills; fluent verbal and written English
• Excellent organizational and time-management skills, able to prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment

Why Choose Premier Research? 

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-BC1

#Remote

Description

Description

Description

Description

Description

What You’llBeDoing: 

• Responsible for the oversight of recruitment and line management of data operations staff including staff resourcing, communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; developing, coordinating, and enforcing policies, procedures, and productivity standards
• Build and maintain long-term rapport and relationships with customers to ensure their expectations are continuously exceeded
• Develop plans and processes which reset the bar at a higher level and move past organic or incremental improvements as the measure of success
• Supports business development activities by taking ownership of project costing estimates, proposal reviews/change order management and proposal defenses
• Manages the resource allocation and utilization for his or her team in conjunction with the project goals for the department
• Administers financial compensation for direct reports and proposes adjustments (e.g., promotions, market adjustments, etc.) to departmental senior management

WhatWeAreSearchingFor:

• Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, programming, clinical, biological, scientific, or health-related field, or equivalent combination of education, training and experience
• 7 to 10 years of people management with proven ability to supervise staff, encourage teamwork and develop team capabilities.  
• 7 to 10 years of practical experience managing clinical trial data or commercial clinical trial management systems and/or electronic data capture products. Clinical operations experience preferred.
• Strong leadership skills; ability to build and motivate teams to achieve results; ability to influence and inspire action through strong decision-making skills
• Ideally has experience within the Sponsor-Embedded / Functional Services Provider model 
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. 

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

Description

Premier Consulting, a division of Premier Research, is seeking a Director, Regulatory Affairs. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.

What You’ll Be Doing:

·       Develop and execute international and regional strategies and contingencies for assigned projects and mentor junior staff in same.

·       Lead both international and regional regulatory teams on assigned projects

·       Develop and implement creative approaches to ensure regulatory success

·       Provide efficient and effective Regulatory representation across the organization and act as a key player in interactions with the Food and Drug Administration (FDA) and other regulatory agencies

·       Lead the preparation of submissions, which may include INDs, briefing documents, orphan drug applications, breakthrough designations, and NDAs/BLAs/MAAs

·       Provide regulatory strategy, and review and edit complex submissions and regulatory justifications for waivers and potential reductions in development program scope, etc.

·       Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines Willingness to acquire new areas of expertise.

What We Are Searching For:

·      Masters’ degree, or international equivalent from an accredited institution, in science or health related field; PhD preferred

·      5+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry; an advanced degree will be considered in lieu of a portion of industry experience 

·      7+ years progressive regulatory affairs experience in a CRO, pharmaceutical, device/diagnostics or biotechnology company preferred

·      5+ years supervisory/management experience

·      Demonstrated experience interacting with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies. APAC experience a significant plus. US regulatory experience highly preferred. 

Why Choose Premier Research?

·      Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.

·       Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.

·      Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.  

#LI-CI1

Description

Premier Research is looking for a Project Manager II/Senior Project Manager to join our Cell & Gene Therapy team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech^SM. Join us and build your future here.

What you’ll be doing:  

• Ensures successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery 
• Maintains and evaluates study progress by using company tracking systems, project timelines and budget reviews and projecting profitability  
• Manages the project team to ensure study progress is according to both client and Premier Research requirements and in compliance with standard Premier Research processes, policies and procedures 
• Ensures effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally 
• Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training 
• Prepares forecasts for staff utilization over the life of the study and ensures adequate resourcing is available to meet project deliverables and milestones 

What we are searching for in a Project Manager II:   

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience 
• 6 years of clinical research experience
• 3 years of project management experience, preferably with a CRO
• Experience in Cell and Gene Therapy

What we are searching for in a Senior Project Manager:   

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience 
• 8 years of clinical research experience
• 5 years of project management experience, preferably with a CRO
• Experience working globally
• Experience in Cell and Gene Therapy

Why choose Premier Research? 

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and most importantly about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status. 

#LI-KP1

Description

The Vendor Category Manager in partnership with the Procurement and Project Delivery will provide End to End oversight for Operational Vendor Strategy by assigned Vendor Category/ies in their entirety and complexity. This includes all necessary actions, communication and participation required for gatekeeping approved strategies for each vendor category.

The Vendor Category Manager will also establish and review baseline metrics and KPI’s for each Vendor by Category and maintain open communication with Procurement and Project Delivery on Vendor ratings.

What you'll be doing:

• Management of Vendor Category needs and assessment of new vendors and services, establish, develop and maintain relationship with the Vendors in the assigned category/ies appropriate for their engagement (includes meetings, written communication, business reviews, escalations, etc.); leads business reviews and ad hoc meetings as necessary
• Partners with Project Delivery as a Subject Matter Expert for Vendor strategy during the proposal and setup of studies and participate in the development and execution of approved strategies for assigned categories
• Collect and analyze agreed metrics, KPIs and feedback received from Project teams in order to be able to assess delivery, compare Vendors in the category and recommend the best fit for a study based on specifics; participate in the building of dashboards to allow proper reporting
•  Act as facilitator in escalation calls with Sponsor, Vendor and Project team to seek solutions; collect resolutions in a data base for future reference and collaborate with all groups working on the Vendor Management Process to ensure alignment and proper execution of the agreed services from a Vendor
• May need to travel to meet Vendors depending on the category (less than 20% of the time)

What we are searching for:

• Undergraduate degree or its international equivalent in a relevant field from an accredited institution or a combination of education and experience
• 5-8 years’ experience in project trial delivery or similar positions
• Thorough understanding of Clinical Trial Execution required
• CRO Experience Required
• Vendor Interactions Experience preferred

#REMOTE
#LI-SK1

Description

Description

Description

Description