The Medical Writing team at Moderna is looking for an agile, self-motivated, and submissions experienced individual to serve as a Director, Medical Writing to support clinical project teams to meet their clinical document deliverables. This individual will be responsible for managing a group of Medical Writer and will oversee plans /coordinates and help to course correct as necessary to ensure timely completion of clinical writing projects. 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:
Here's What You'll Bring to the Table:
- Serve as the MW Lead contributing and leading a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, and regulatory submissions including briefing books and regulatory responses.
- Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.
- Provide support for QC of complex clinical documents
- Manage timelines and communicate with team stake holders to maintain awareness of expectations, milestones, and deliverables.
- May include participation in initiatives such as document templates, writing style guide, and support for document reviewing/authoring tools
- Lead significant workstreams that involve work across departments and with external vendors
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Minimum of bachelor's degree or equivalent in scientific or medical discipline; Advanced degree preferred
- Minimum of 8 years medical writing experience with a total of more than 10 years of pharmaceutical or biotech experience required
- Strong submissions experience
- Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
- Experience producing high quality clinical 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
- Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners 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 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!
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.