Principal Medical Writer
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY, United States
- Start date
- Jul 16, 2019
View more
- Discipline
- Clinical, Medical Writing
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Summary:
The Principal Medical Writer will be responsible for liaising with the appropriate matrixed team members to shape and review content of documents, and to follow up with other functional groups for materials needed for document completion, reviewing documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR, tracking all documents in a therapeutic area, overseeing more junior writers working on documents in their therapeutic area, and leading the Medical Writing effort in a clinical filing. The Principal Medical Writer will be responsible for ensuring adherence to department guidelines, templates, SOPs, and regulatory guidelines for all Medical Writing documents provided for their therapeutic area. The individual in this position will work independently writing CSRs, CSPs, CSP amendments, IBs and IB updates, and Clinical Summaries in a variety of therapeutic areas. Work closely with Medical Directors, Biostatisticians and/or regulatory liaisons to develop high quality clinical documents.
Job Duties:
Working with the clinical team, the Principal Medical Writer will be responsible for writing following documents:
o Clinical Study Protocols
o Clinical Study Protocol Amendments
o Clinical Study Reports
o Investigator brochures
o Clinical Summaries
o Other documents, as needed
Requirements:
MUST BE BASED at our corporate HQ in Tarrytown, NY
This individual must:
• 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 escalate 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 correct 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.
• Show managerial courage in a matrixed organization
• Be a team player
• Have a good working knowledge 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 industry experience to include a minimum of 8+ years Medical Writing experience (relevant advanced degree may offset some of the experience requirement)
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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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