Job Description

Senior Medical Writer (Pharmaceutical)

Location San Rafael, CA. (Hybrid 2 days)

12 Month Assignment

Pay Rate: $70/hr.

On behalf of our client a pharmaceutical company specializing in the development of therapeutics for patients dealing with rare genetic life-threatening diseases. The Senior 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.

Responsibilities:

• Draft and edit documents for regulatory submissions including CTDs and RtQs.
• Prepare and review documents for clinical studies, such as protocols, amendments, and informed consent forms.
• Develop documents for reporting aggregate safety and efficacy data, including investigator’s brochures and safety reports (PSURs, DSURs).
• Manage document preparation timelines, team meetings, and review processes.
• Ensure compliance with departmental procedures, industry standards, and regulatory requirements.
• Collaborate effectively with cross-functional teams.

Education and Experience:

• Bachelor’s degree or higher; scientific background preferred.
• Evidence of career development in medical writing (e.g., AMWA or EMWA certification) desirable.
• 6+ years of experience as a medical writer in the pharmaceutical industry.
• Familiarity with drug development phases, clinical study protocols, and documentation.
• Experience in protocol development and writing clinical study reports (CRs).
• Preferred experience in writing INDs, BLA/NDAs, and familiarity with AMA, CBE, and Chicago Style Manuals.
• Proficiency in Microsoft Word, Excel, and PowerPoint; familiarity with medical dictionaries and regulatory guidelines.

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