Sr. Medical Writer

Position : Senior Medical Writer , Req# : 101-1

Location : 100% Remote (Can work EST or PST Hours)

Duration : 6+  Months Contract with the possibility of extension

Job Description :

This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable the client to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.

Education & Experience required :

• Bachelor’s or higher degree required; scientific focus desirable.
• Minimum requirement : Experience in medical writing.
• Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

EXPERIENCE : Relevant Experience

Fulfils one of the following :

Clinical Studies

Medical Writing

Computer / office equipment Skills

Regulatory

Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).

Prior familiarity with standard eCTD IND / NDA work, including :

Project Management

Communication

Responsibilities :

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