Job Description

The Role:
The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced Manager to serve as an integral part of the Medical Writing Team to support clinical project teams, within the Oncology therapeutic area, 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\xe2\x80\x99s What You\xe2\x80\x99ll 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\xe2\x80\x99s 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 key stake holders to maintain awareness of expectations, milestones, and deliverables.

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

Work collaboratively with multifunctional teams and stakeholders and will be relentless in pursuing successful outcomes

Provide support for QC of complex clinical documents

Here\xe2\x80\x99s What You\xe2\x80\x99ll Bring to the Table:
Minimum of bachelor\xe2\x80\x99s degree or equivalent in scientific or medical discipline; Advanced degree preferred.

Minimum of 5 years medical writing experience in pharmaceutical or biotech; with a minimum of 1- 2 years of Oncology medical writing experience; 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

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/levels available within other therapeutic areas of Moderna.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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.

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