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A selection of jobs from the previous newsleterrs.

ILLUSTRATIVE MATHEMATICS is hiring a Remote Paralegal

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Regulatory Professionals is hiring a Remote Director, Regulatory Affairs

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

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Premier Research is hiring a Remote Director, Regulatory Affairs

Description

Position at Premier Consulting

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

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Imperva is hiring a Remote Contract- Corporate Counsel

Why Imperva Legal?

  • small and creative legal team with ample opportunities for significant and meaningful contribution
  • cross-functional projects, experiences and learning opportunities that will expand your expertise and knowledge base
  • transparent, innovative management and collaborative cross functional atmosphere

Why You?


●   You aim to be a key contributor and innovator
●   You are curious and want to expand your expertise into new areas of law.
●   You enjoy working with non-lawyers and are eager to collaborate with others
●   You have a solid foundation in your area of expertise, but can issue spot and problem solve in diverse areas of law.
●   You are confident in your judgment, but open to feedback and  collaborative analysis.
●   You have excellent written, verbal, and visual communication skills.  

The Opportunity


Imperva is looking for a Contract Corporate Counsel (1099) to serve on our global and innovative and productive legal team.  

We prefer that you be based in the Bay Area, but our team is currently 100% remote and we’ll consider candidates in other locations.  Our headquarters are in San Mateo, CA, if you prefer to work from the office.   

Your Responsibilities will include at least the following, but there is plenty of opportunity to expand into other areas.


  • Review and negotiate vendor agreements to fulfill Imperva’s procurement needs and effectively resolve contract scope, obligations and liability issues.
  • Advise product teams on compliance issues.  
  • Partner with other Imperva attorneys and outside counsel to proactively identify areas of operational risk and improve internal processes.

Requirements

  • Qualified attorney in your jurisdiction, with impressive academic credentials and demonstrated record of success. 
  • 5-7 years of experience, preferably spanning law firm and in-house work
  • background in corporate governance and late-stage private company compliance matters 
  • experience negotiating sophisticated commercial agreements, including vendor and software licensing agreements.  

Our Company:


Imperva is an analyst-recognized, cybersecurity leader—championing the fight to secure data and applications wherever they reside. Once deployed, our solutions proactively identify, evaluate, and eliminate current and emerging threats, so you never have to choose between innovating for your customers and protecting what matters most. Imperva—Protect the pulse of your business. Learn more: www.imperva.com, our blog, on Twitter.

Rewards:


Imperva offers a competitive compensation package that includes base salary, medical, flexible time off and more. It’s an exciting time to work in the security space. Check out our products and services at www.imperva.com and career opportunities at www.imperva.com/careers

Legal Notice:

Imperva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, pregnancy, age, sexual orientation, gender identity, marital status, protected veteran status, medical condition or disability, or any other characteristic protected by law.   

 

#LI-NP1

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Design To Delivery Inc is hiring a Remote Contract Specialist

Contract Specialist - Design To Delivery Inc - Career Page

Resourcing Edge is hiring a Remote Benefits Specialist

Benefits Specialist - Resourcing Edge - Career Page

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+30d

Senior Counsel, Commercial

SeatGeekRemote - United States

SeatGeek is hiring a Remote Senior Counsel, Commercial

SeatGeek believes live events are powerful experiences that unite humans. With our technological savvy and fan-first attitude we’re simplifying and modernizing the ticketing industry.

By catering to both consumers and enterprises, we’re powering a new, open entertainment ecosystem where fans have effortless access to experiences, and teams, venues, and shows have seamless access to their audiences. Because everyone should expect more from ticketing.

As Senior Counsel reporting to the Deputy General Counsel, you will help to accelerate the momentum of SeatGeek’s growth by focusing on facilitating deal negotiation and execution for our enterprise SaaS business. In addition to strong legal skills, we’re looking for someone with the leadership acumen and credibility to inspire confidence, build trust and successfully work with a number of cross-functional teams to solicit input and drive the contract process toward successful execution.

What you'll do

  • Draft, negotiate and structure complex enterprise SaaS and sponsorship agreements with major sports franchises and other strategic partners, working closely with our enterprise sales team and prospective enterprise clients
  • Review, draft, and negotiate a wide variety of other commercial agreements and amendments, including analytics, product integration, licensing, professional services, and other general vendor and operations agreements
  • Stay apprised of ever-changing laws affecting the SeatGeek business, and ensure contractual terms comply with state and federal law
  • Work closely with teams across product, finance, data, marketing and client support to ensure terms align with company objectives and priorities
  • Help develop processes to ensure ongoing compliance with contractual commitments and provide practical, solutions-oriented advice to help client teams navigate issues that may arise in the customer relationship such as service outages, SLA remedies, etc.
  • Develop and maintain forms for key agreements and a contract playbook related to material terms
  • Assist with defining and implementing best practices around workflow and process to further scale the legal department
  • Assist with other legal matters as requested

What you have

  • J.D. degree from a top accredited institution and admission to practice (or in-house eligibility) to practice law in New York
  • 7+ years of post-J.D. experience, ideally including both top law firm and commercial counsel experience as part of an in-house legal team
  • Outstanding drafting, communication and analytical skills with impeccable attention to detail and a strong sense of ownership and accountability
  • Substantial experience drafting and negotiating complex commercial agreements involving technology, including licensing agreements (data licensing, SaaS agreements, etc.)
  • Working knowledge of privacy laws as they relate to commercial contracts
  • Demonstrated ability to handle a broad range of responsibilities and prioritize in a fast-paced environment
  • Ability to balance legal risk mitigation against key business objectives and risks
  • Growth mindset with a strong desire to grow professionally, upskill, learn about new products, technologies and processes, and remain agile and adaptable

Perks

  • Equity stake
  • Flexible work environment, allowing you to work as many days a week in the office as you’d like or 100% remotely
  • A WFH stipend to support your home office setup
  • Flexible PTO
  • Up to 16 weeks of paid family leave
  • 401(k) matching program
  • Health, vision, dental, and life insurance
  • Annual subscriptions to Headspace, Ginger.io, and One Medical 
  • $120 a month to spend on tickets to live events
  • Annual subscription to Spotify, Apple Music, or Amazon music

 


The salary range for this role is $160,000- $245,000. Actual compensation packages within that range are based on a wide array of factors unique to each candidate, including but not limited to skill set, years and depth of experience, certifications, and specific location.

SeatGeek is committed to providing equal employment opportunities to all employees and applicants for employment regardless of race, color, religion, creed, age, national origin or ancestry, ethnicity, sex, sexual orientation, gender identity or expression, disability, military or veteran status, or any other category protected by federal, state, or local law. As an equal opportunities employer, we recognize that diversity is a positive attribute and we welcome the differences and benefits that a diverse culture brings. Come join us!

#LI-Remote
+30d

Senior Compliance Manager

Hazel HealthSan Francisco Bay Area | Remote

Hazel Health is hiring a Remote Senior Compliance Manager

Hazel partners with schools and families to provide physical and mental virtual health care that helps students feel better and get back to learning. As telehealth becomes more and more relevant in the lives of children, Hazel is experiencing tremendous company growth. Our innovative response to our nation’s call for equitable, affordable, and safe virtual access to healthcare has been recognized by Fast Company as “one of the world’s most innovative places to work” in 2023. 

Helping students and their families feel better takes a team of smart, dedicated people. As an integral member of the Hazel team, you will…

  • Make an Impact: Work with a team that is increasing equitable access of quality health care experiences for students and their families
  • Enable Scale: Work with a team that is building and professionalizing a high growth high impact social enterprise
  • Feel Valued: Work with a team that is being compensated competitively, developed professionally, and celebrated frequently for making a meaningful difference

Check us out at Hazel Health Careers

The Role: Senior Compliance and Privacy Manager

Location:Irving, TX or remote

About This Role:

We are looking for dynamic, empathetic, and action-oriented individuals to join our exciting Compliance team. 

As part of the growing Hazel Compliance Team, you will be responsible for the implementation of a robust compliance and privacy management program and ensuring Hazel’s adherence to federal, state, and local regulations. This important role requires an understanding of the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA, Healthcare Billing Compliance, Multi-State Regulations.

What You’ll Do:

  • Implementation of a strategic and comprehensive compliance and privacy program that defines, develops, maintains and implements policies and processes that enable consistent, effective compliance and privacy practices which minimize risk and ensure the confidentiality of protected health information (PHI)
  • Develops compliance risk assessment and integrates into an overall compliance plan.
  • Aligns with Information Systems to review all system-related information security plans throughout the organization's network
  • Accountable for development and management of a robust and effective healthcare compliance program through the monitoring of the seven elements.
  • Help to create a compliance strategy based on organization priorities, national laws/regulations and risk management priorities.
  • Drive and manage projects assigned as a result of the strategy.
  • Oversee annual external security and privacy audits. Create action plans to address areas of opportunities and provide updates to Hazel’s Audit Committee
  • Coordinates with the Human Resources Department to ensure the delivery of an effective compliance and privacy training program, including appropriate introductory training for new employees and ongoing training for existing staff, including the Board of Directors
  • Manage and oversee the  medical records request process and adherence to regulations in responding to such requests
  • Expectation of maintaining accurate records with integrity

What Excites us:

  • Passionate for our mission to transform healthcare for all children
  • Bachelor’s degree required
  • 5+ years in a healthcare compliance role, experience with Family Educational Rights and Privacy Act (FERPA) a plus
  • Certification in Compliance Healthcare and Healthcare Privacy preferred
  • Recommended privacy certification such as Certified in Healthcare Privacy Certification Security (CHPC) and/or other revenue cycle healthcare industry related credential, e.g. RHIA, RHIT or CPC.

Total compensation for this role is market competitive, with a base salary range of 128,500 to 155,500, a 401k match, healthcare coverage, paid-time off, and a broad range of other benefits and perks. Review our benefits at Hazel Health Benefits.

Our Hiring Process:

At Hazel, we value your time and aim to run a hiring process that takes no more than 4 weeks, involving interview activities customized for each role and requisite skill set. We understand that interviewing for a new job can be a big change and the Hazel Recruitment Team is excited to guide you through this process.

We believe talent is everywhere, and so is opportunity. While we have physical offices in San Francisco and Dallas, we have embraced working remotely throughout the United States. While some roles may require proximity to our San Francisco or Dallas offices, remote roles can sit in any of the following states: AZ, CA, CO, DC, DE, FL, GA, HI, IL, ME, MD, MA, MI, MO, NE, NV, NJ, NM, NY, NC, OR, PA, SC, TN, TX, VT, VA, WA and WI. Please only apply if you live and work full-time in one of the states listed above or plan to relocate to one of these states before starting your employment with Hazel. State locations and specifics are subject to change as our hiring requirements shift.

We are committed to creating a diverse, inclusive and equitable workplace. Hazel Health values the minds, experiences and perspectives of people from all walks of life. We are proud to value diversity and be an equal opportunity employer. Qualified candidates with arrest and conviction records will be considered for employment in accordance with the Fair Hiring laws. Learn more about working with us at Hazel Health Life.

RxAnte is hiring a Remote IT Compliance Analyst - Remote

Company Profile 

Over the next ten years, there will be at least 4.6 million hospitalizations from the misuse of prescription drugs in people 65 or older, resulting in $528 billion in annual avoidable costs. RxAnte is on a mission to improve people’s health by helping them get more from medicines.  A rapidly growing tech-enabled healthcare services company with over 30 million lives under management, RxAnte has become a leading provider of value-based pharmacy care management solutions for health plans.  RxAnte launched Mosaic Pharmacy Service in 2019, a wholly owned subsidiary designed to offer pharmacy and chronic care management services for our clients’ most medically complex and vulnerable members. Using data, advanced analytics, specialized software and pharmacy automation, Mosaic is transforming the pharmacy experience for medically complex seniors while also helping payers achieve their quality improvement and cost savings objectives. 

 

Job Overview

An IT Compliance Analyst is responsible for ensuring that RxAnte adheres to regulatory and compliance requirements and RxAnte standards related to information technology. Possessing excellent analytical, communication, and problem-solving skills, the IT compliance analyst will monitor and assess compliance with security, privacy, and data protection regulations such as HIPAA, CMS FDR, PCI-DSS, GLBA and requirements of clients, and vendors. The IT compliance Analyst reports to theVP, IT Operations and Information Security Officer.This full-time position is a hybrid work arrangement with up to three days per week spent at our Sterling, Virginia, offices as needed.

 

Essential Duties and Responsibilities:

  • Support client, vendor and company initiated compliance assessments and questionnaires. .
  • Maintain Critical System Account Reports and User account Reports.
  • Manage and review Information Security and Compliance Program requirements, including: Position Risk Designations, Security Event Reviews, Port Reviews, System Record Reviews, Covered Entity PHI Delivery Reviews, and Installed Software Reviews.
  • Conduct Technical reviews - Pen Test, vulnerability scans, training, and testing audits.
  • Support and assist in HITRUST – SOC2 Audits and Certifications.
  • Manage BC/DR Training, Testing, Reporting, and Remediation on a quarterly basis.
  • Conduct Incident Response Training, Testing, Reporting, and Remediation.
  • Conduct diligence on Company and vendor products and services from a compliance and risk standpoint.
  • Provide guidance for analyzing comprehensive risk management.
  • Ensure organization stays up to date with training needs and requirements.
  • Ensure policies and procedures are reviewed annually and remain current and effective.
  • Develop and implement PCI/NACHA additional compliance requirements tied to Mosaic LOB
  • Monitor and maintain Data and Record Retention from compliance and client requirements across all company systems and services, as well as vendors.
  • Support HR and IT in change of employment and associated review requirements.
  • Collaborate with HR to implement enhanced and revised training, background, and drug screening requirements, and IT onboarding and offboarding processes.
  • Assist with other IT and compliance related projects as requested.

 

Required Skills/Abilities:

  • Excellent verbal and written communication skills.
  • Excellent interpersonal skillswith ability to explain technical issues to technical and nontechnical staff.
  • Strong analytical and problem-solving skills.
  • Superior understanding of computer and networking technologies and software systems.
  • Excellent time management skills.
  • Proficient with Microsoft Office Suite or related software.
  • Proficient with or able to quickly learn to use a broad array of networking and systems hardware and software.


Education and Experience:

  • Bachelor's degree in computer science, information technology, or a related field is typically required.
  • Experience in IT auditing, risk management, or compliance is also preferred.
  • Desired to have professional certifications such as Certified Information Systems Auditor (CISA) or Certified in Risk and Information Systems Control (CRISC).
  • Working knowledge of privacy, security and data regulations, such asHIPAA, CMS FDR, PCI-DSS, and GLBA.
  • At least three to five years of related experience, preferably in the healthcare industry. 

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