Clinical Medical Writer
The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced individual to serve as a 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
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 four years medical writing experience
- 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
- 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
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale, and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients
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.