Director, Clinical Medical Writer

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
June 29 2019
Ref
R1144
Discipline
Life Sciences, Biology
Organization Type
Biotech
Director, Clinical Medical Writer

The Role:

The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced individual to serve as a director of medical writer to support clinical project teams to meet their clinical document deliverables. Plans and coordinates timelines 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:
  • Serve as the medical writer contributing to a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, and regulatory submissions including briefing books
  • 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 or with external vendors


Here's What You'll Bring to the Table:
  • Minimum of bachelor's degree or equivalent in scientific or medical discipline; Advanced degree preferred
  • Minimum of six years medical writing experience with a total of more than 10 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 documents
  • Basic 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


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-FC1

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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