Job Description

Position: Senior Regulatory Medical Writer, Req#: 36071191

Location: San Rafael, CA, Hybrid (1-2 days in office to align with company policy).

Duration: 12+ Months Contract

Role Description

Seeking candidates who are regulatory medical writers (not Medical Communication)

The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

EDUCATION & SKILLS:

• Bachelor’s or higher degree; scientific focus desirable.
• Evidence of medical writing career development is desirable, e.g., American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through the Drug Information Association.
• At least 6+ years of experience required

Fulfills one of the following:

• Medical writer in the pharmaceutical industry
• Medical or scientific writing experience as a primary job responsibility

Skills:

• Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
• Experience writing, reviewing, or editing INDs and BLA/NDAs is highly preferred.
• Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
• Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
• Ability to interpret basic tabular and graphical clinical data presentations.
• Ability to create basic tables using AMA style (e.g., Schedule of Events).
• Intermediate applied knowledge of basic clinical laboratory tests.
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).

Key Responsibilities

• Drafts and edits documents used for submissions including CTDs and RtQs
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)

SUPERVISOR RESPONSIBILITY None.

CONTACTS

• Clinical Medical Writing, Biostatistics, Clinical Data Management, Statistical Programming, Clinical Operations, Medical Affairs, Medical Directors, Regulatory Affairs, Legal, Commercial, Pharmacology/Toxicology, Corporate Compliance, Project management, Pharmacovigilance.

EQUIPMENT

• Access to corporate computer network, production computing environment, and MS Windows software.

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