Senior Manager, Medical Writing (Rare Disease, Autoimmune, Cardiovascular)

The Role:

The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced Senior Manager to serve as an integral part of the Medical Writing Team to support clinical project teams, within the Rare Disease, Autoimmune and Cardiovascular therapeutic areas, to meet their clinical document deliverables. The successful candidate will be detailed oriented, self-directed and with the ability to be flexible and manage workload to meet project timelines.

Heres What Youll Do:

• Serve as the medical writing Lead contributing to a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, and other regulatory submissions documents.

• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.

• Plan, coordinate, and oversee clinical study registration and results posting in various clinical trial disclosure platforms.

• Plan and coordinate timelines to ensure timely completion of clinical writing projects.

• Manage timelines and communicate with team stake holders to maintain awareness of expectations, milestones, and deliverables.

• Lead significant workstreams that involve work across departments or with external vendors

• Provide support for QC of complex clinical documents

Heres What Youll Bring to the Table:

• Minimum of bachelors degree or equivalent in scientific or medical discipline; Advanced degree preferred

• Minimum of 6-8 years medical writing experience with at least 5 years of pharmaceutical or biotech experience required

• Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy

• Experience producing high quality clinical and regulatory submission documents

• Strong project management and organizational skills

• Strong organizational/prioritization skills for the management of multiple concurrent projects

• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and experience and skill performing medical literature searches

• Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes

Additional Information:

• Hybrid work arrangement available for those local to our Cambridge, MA headquarters or fully remote for qualified candidates who currently reside within the continental United States with ability to travel onsite as necessary

• Multiple vacancies available

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 year-end shutdown
  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!

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 a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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