Senior Medical Writer

Location
Tarrytown, New York
Posted
Mar 20, 2018
Ref
11437BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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

Overseen by a more senior staff member, the Medical Writer will liaise 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. The Medical Writer will be expected to resolve issues and escalate problems, as necessary. The individual in this position will write CSRs, CSPs, CSP amendments, narratives, IBs and IB updates in a variety of therapeutic areas. Training on Clinical Summaries and other regulatory documents may be provided.

Responsibilities

• Working with the clinical teams, the Medical Writer will be responsible for writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Narratives, Investigator's Brochures. The work will be overseen (reviewed and edited, as necessary) by a more senior staff member, however, the Medical Writer is expected to drive the project, track deliverables, and ensure timely completion.
• Liaises with study director and/or medical monitors to shape and review content of documents. Follows up with other functional groups for materials needed for document completion.
• Tracks writing projects, and ensures adherence to regulatory guidelines and department document standards.
• Ensures maintenance of document standardization through use of model documents/templates and appropriate peer review.
• Updates job knowledge by tracking changes in writing guidelines; participates in educational opportunities, reads professional publications and maintains personal networks.

Requirements

Education
• Bachelor's degree (advanced degree preferred)
Experience
• Minimum of 1+ years of industry experience
• Working knowledge of the clinical research process and regulations/guidelines required. Scientific and technical reading, writing and editing skills required.
• Strong organizational, interpersonal and written communication skills. Must be able to communicate effectively in large or small group settings. Effective influence and relationship management skills required.
• 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.
• Have strong organizational, interpersonal and communication skills, and be able to develop and present varied and unique ideas
• Expected to have a good working knowledge of MS WORD, Adobe Acrobat, and use of one or more EDM systems.

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.

Requisition Number: 11437BR