Sr/Director, Medical Writing

Director/Sr. Director, Medical Writing
Remote - Greater Boston - United States

Seeking highly experienced and motivated Medical Writing Leader to join a small group with an established global pharmaceutical organization in the Boston area. This new incumbent will work closely with upper management and will be very involved with all regulatory writing strategies. Expected to provide sound 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 SME for 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. There will be no direct reports; however, will be considered upper management's right-hand and will Lead the team and external contacts.

Responsibilities:

• This role will work collaboratively with our cross-functional teams and external partners to ensure that regulatory documents generated by the company meet the highest GCP, GDP, patient safety, and quality standards.
• Lead Author of regulatory documents for the clinical development programs.
• Responsible for leading, coordinating, compiling, and producing routine regulatory submissions/amendments.
• Lead submission document writing strategies (BLA, NDA, MAA)
• Manage and collaborate with stakeholders globally - clinical, nonclinical/pharmacology, pharmacokinetics, biostatistics
• Tracking all 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.
• 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 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)
• 8+ years of relevant regulatory writing industry experience in the biopharmaceutical industry
• Strong skills and ability to prepare any type of clinical regulatory document with very minimal supervision.
• Working experience of ICH and other regulatory guidances and IND, NDA, BLA process.
• Experience as a Submission Lead (CTD submissions)
• Antiviral, vaccines experience is highly preferred but not essential
• Prior hands-on leadership and management experience
• Regulatory writing experience for both US and EU

If interested in learning more, please contact Bria Gaber at bria.gaber@biotalent.com for more information.