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Associate Director, Aggregate Safety Reporting

Moderna

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Cambridge, MA
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Job Description

As posted by the hiring company

Job Overview:

The Role:

Join Moderna Therapeutics’ enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development. Reporting to the Director, Aggregate Safety Reporting, the Associate Director, Aggregate Safety Reporting will be responsible for supporting Moderna’s aggregate reports and other key safety-focused documents for submission to regulatory agencies. This leader will ensure the highest global standards of quality and compliance with all aggregate safety reporting obligations for all Moderna products throughout the life cycle. This leader will be instrumental in ensuring the availability of high-quality data for aggregate reports and other key safety-focused documents for submission to regulatory agencies.

This is an exciting time to join Moderna as our COVID-19 vaccine (mRNA 1273) continues to grow globally and we accelerate our pipeline and late phase development efforts, thereby poising Moderna for substantial growth in the upcoming years. This role will have the opportunity to make critical contributions to Moderna’s future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.

Here’s What You’ll Do:

  • Responsible for delivery of aggregate safety reports (ASRs) and support delivery of risk management plan (RMP) documents for investigational and marketed products

  • Support the authoring and editing of periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, medical colleagues, and PV Project Management.

  • Assist in authoring, writing and editing RMPs in collaboration with Clinical Safety and Risk Management (CSRM), physicians, safety scientists, and medical colleagues

  • Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues

  • Review applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for aggregate safety reports

  • Oversee compliance, quality, procedures, regulations, timeliness, and consistency of scheduled and unscheduled aggregate reports.

  • Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other reports and/or deliverables

  • Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission

  • Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents

  • Participates in cross-functional teams to create new policies to develop and promote best practices, processes, identify new tools, and develop new policies to promote consistent aggregate reports excellence, ensure safe and appropriate use of our products and monitor performance trends and drive continue process improvements related to aggregate reports

  • Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons

  • Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues

  • Draft regulatory response documents such as PRAC assessment reports

  • Draft other medical writing deliverables as needed

  • Management of vendor activities related to aggregate reports including responsibility for quality and compliance with SOPs for the vendor staff

  • Support PV Operations, PV audits and inspections

Here’s What You’ll Bring to the Table:

  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background

  • Minimum of 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance

  • Excellent written and verbal communication skills with the ability to interpret and present safety data and interact across multiple functions

  • Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process

  • Ability to manage/ lead in a matrix environment

  • Knowledge of drug safety/pharmacovigilance practices and tools

  • Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision

  • Background in vaccines is a plus

  • Demonstrated ability to develop, execute and follow-through complex projects to completion

  • Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

  • Independently motivated, detail oriented and strong problem-solving ability with strong scientific, analytical and conceptual skills

  • Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities

  • Proficiency in Microsoft Word, Excel, and PowerPoint

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous paid time off, including:
    • Vacation, sick time and holidays
    • Volunteer time to participate within your community
    • Discretionary winter shut down
    • Paid sabbatical after 5 years; every 3 years thereafter
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Free parking or subsidized commuter passes
  • Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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