Associate Director, Medical Writing

Associate Director, Medical Writing

Remote - United States

Seeking an experienced Associate Director of Medical Writing to provide guidance, leadership, and expertise to the project teams and outside vendors, and external contacts. This position is responsible for writing, editing, and coordinating content for federal clinical or regulatory projects while serving as the primary Lead Writer with internal and external teams. Ensures that all strategies are in place and executed to support the authoring, review, and approval of documents to ensure the accuracy of all complex clinical documents. The Associate Director is responsible to determine and drive the medical writing strategy for their novel therapeutics for CNS patients.

• You will be responsible for leading, coordinating, compiling, and producing routine regulatory submissions and amendments
• Leads submission writing strategies (IND, NDA, BLA)
• You will be responsible for tracking timelines on regulatory deliverables as well as providing project updates - this will include highlighting any risks that might impact the ability to achieve corporate goals.
• Author Clinical Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Briefing Books, and IND modules, DSURs, Briefing Books, and Regulatory Responses.
• Experience writing Protocols from start to finish and is a key player in the strategy development of ideas to further develop the company's programs.
• May be responsible for activities for one or more compounds and may contribute to major submissions.
• Program Management responsibilities in creating and negotiating timelines, budgets, risk analysis assessments, etc.
• You will ensure that all regulatory submission documents are fully compliant with internal document standards. You will work with the wider team to ensure that all regulatory practices and strategies are fully executed, and all submissions are evaluated and reviewed thoroughly to ensure the following: completeness, well-organized, scientifically accurate, of high quality, in regulatory compliance, and presented in a manner that facilitates agency review.
• Lead the efficient planning and authoring of clinical submissions and provide authoritative support and advice to teams both directly and through oversight of internal or vendor staff.

Requirements:

• Bachelor's degree in a Scientific discipline required (advanced degrees are highly preferred)
• 4-5 years of relevant regulatory medical writing experience within the biopharmaceutical industry
• 2-3 years minimum of regulatory document project management expertise.
• AMWA certification is highly preferred (not required).
• Experience as a Submission Lead (CTD submissions); high-level content writing experience with clinical development regulatory documents.
• Global medical writing experience for both US and EU

If you meet the above qualifications and are interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com for more information.