Principal Medical Writer
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Basking Ridge, NJ, United States
- Start date
- Apr 12, 2021
View more
- Discipline
- Clinical, Medical Writing
- Required Education
- Other
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
In this role, a typical day might include the following:
Working with the clinical team, you will be responsible for writing following documents:
- Clinical Study Protocols
- Clinical Study Protocol Amendments
- Clinical Study Reports
- Investigator brochures
- Clinical Summaries
- Other documents, as needed
We expect you will:
- Have written CSRs, clinical protocols, clinical protocol amendments, IBs, IB updates and clinical summaries for NDA/BLA/MAA, etc.
- Understand the general document content for each clinical document type, how the individual document types fit into a filing and feed from one to the next, and how to message appropriately across the clinical documents in a filing.
- Expected to resolve issues and advance problems, as necessary
- Contribute to document strategy in a therapeutic area.
- Lead other writers in large projects, providing framework for document content.
- Participate actively in meetings; communicate opinions and influence decisions;
- Be able to identify the accurate parties for a document content decision, and if a discussion is faltering, bring it back on track with minimal fuss.
- Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
- We expect you will show managerial courage in a matrixed organization
- Have a solid understanding of PDF, and Project. Skilled in use of MS WORD. Has used 1 or more EDM systems
Bachelor's Degree and 8-10 years relevant proven experience to include a minimum of 8+ years Medical Writing experience (relevant advanced degree may offset some of the experience requirement)
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-EG1
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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