Associate Director of Medical Writing

Associate Director, Medical Writing (Vaccines)

New Jersey or Boston - United States

Seeking highly experienced and motivated Medical Writing Leader to join a small group with a leading global pharmaceutical organization in NJ. This new hire will 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 technical contact with internal and external teams. Ensures that all strategies are in place and executed to support the authoring, review, approval of documents to ensure the accuracy of all complex clinical documents.

• You will be responsible for leading, coordinating, compiling, and producing routine regulatory submissions/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.
• Develop and author Clinical Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Briefing Books, sections of clinical Module 2, and Module 5 summary documents.
• Must write Protocols from start to finish, and, be a key player in the strategy development of ideas to further develop the company's programs.
• May be responsible for medical writing activities for one or more compounds and may contribute to major submissions.
• Mentor and oversee junior MWs and/or vendor medical writers.
• Program Management responsibilities in creating and negotiating timelines, budgets, risk analysis assessments, etc.
• Draft any Regulatory Responses.
• 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)
• 7-10 years of relevant industry experience in the pharmaceutical industry (dependent upon graduate degree)
• Experience as a Submission Lead (CTD submissions)
• Antiviral/Vaccines experience
• Regulatory writing experience for both US and EU

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