Medical Writer Job at Tucker Parker Smith Group (TPS Group) in San Rafael

Direct message the job poster from Tucker Parker Smith Group (TPS Group)

7 month assignment (Potential to extend)

Pay Rate : $52 / 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 Contract Medical Writer applies advanced expertise in document preparation and project management to support the development, drafting, review, and finalization of clinical study documents. These documents are critical for regulatory submissions and publications, ensuring the accurate reporting of clinical study results.

Main Responsibilities :

• Draft and edit documents for regulatory submissions, including Common Technical Documents (CTDs) and Responses to Questions (RtQs).
• Develop and refine documents used in clinical studies, such as protocols, protocol amendments, and informed consent forms.
• Prepare documents for reporting aggregate safety and efficacy data, including investigator brochures and periodic safety reports (e.g., PSURs, DSURs).
• Lead cross-functional study teams in document preparation activities.
• Organize and facilitate meetings to manage timelines, reviews, and the adjudication of comments.
• Ensure adherence to departmental procedures, industry standards, and regulatory guidelines.
• Partner with internal teams across Clinical Medical Writing, Biostatistics, Clinical Operations, Regulatory Affairs, Medical Affairs, and other departments to achieve project goals.
• Provide clear and effective communication to align cross-functional teams on documentation requirements and timelines.

Qualifications and Education :

Please submit a copy of your resume in PDF or Word document to be considered.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Science, Administrative, and Writing / Editing

Industries

Pharmaceutical Manufacturing

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Salary : $52