Manager medical writing

The Role :

The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced individual to serve as an integral part of the Medical Writing Team to support clinical project teams 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.

Here’s What You’ll 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 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

Here’s what we are looking for :

Minimum of bachelor’s degree or equivalent in scientific or medical discipline; Advanced degree preferred.

Minimum of 6 years medical writing experience with at least 5 years of pharmaceutical or biotech experience required; At least 2 years of Oncology medical writing experience is required;

experience with RNA-based therapeutics is a plus.

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, organizational and prioritization skills for the management of multiple concurrent projects.

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 stakeholders and will be relentless in pursuing successful outcomes

• 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.

Last updated : 2022-10-07