Regulatory Medical Writer
Full Time (40 hours) Contract 1 year renewable, White Plains, NY
The Medical Writer/Sr. Medical Writer will write standard Medical Writing documents for a growing biopharmaceutical company. Their focus is in Oncology, Ophthalmology, and Inflammation among others.
Essential Duties and Responsibilities include, but are not limited to the following:
• Works with the clinical team and/or other Medical Writers, to write or help to write the following documents: Clinical Study Protocols, Clinical Study, Protocol Amendments, Clinical Study Reports, Investigator brochure and Other documents, as needed.
• 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.
• 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.
• Resolves issues and escalates problems, as necessary.
• Basic knowledge of the clinical research process and regulations/guidelines required.
• Scientific and technical reading, writing and editing skills required.
• Strong organizational, interpersonal and communication skills.
• Must be able to develop and present varied and unique ideas.
• Effective influence and relationship management skills required.
• Bachelor’s degree (BS) from an accredited college or university
• Minimum 5 years of medical writing experience.
o Previous biotech experience would be helpful
o No need for publications experience
o This position will be working primarily with CSR’s
o Need to include writing sample with CV
Contact: Laura Walton, firstname.lastname@example.org