Principal Medical Writer

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

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:

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.