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Medical Writer

Employer
Regeneron Pharmaceuticals, Inc.
Location
Working from Home
Start date
Aug 17, 2022

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Discipline
Clinical, Clinical Documentation, Medical Writing
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including ophthalmology, hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

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 raise 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.

In this role, a typical day might include the following:

  • 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.

This role might be for you if:

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.

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.

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

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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