Associate Director, Medical Writing
Remote - United States
Seeking highly experienced and independent remote Medical Writer to be a part of an exciting team that is dedicated to leading a revolution in human health focused on autoimmune diseases. Searching for driven talent to head up the medical writing dept within small clinical-stage biotech. There's an upcoming IND filing and need a submission lead to manage all activities.
Responsible for helping to build infrastructure, ie: Templates, SOPs, work processes.
- Manage vendors and external employees while overseeing all clinical document writing management activities
- Assists in developing, compiling, producing, authoring, analyzing, and interpretation medical writing documents (from CSRs, protocols, synopses, SOPs, Batch Records, etc.) to authoring INDs and IMPD sections, briefing documents, and other documents needed to support regulatory interactions and global filings.
- Responsible for leading, coordinating, compiling, and producing routine regulatory submissions/amendments.
- Lead submission document writing strategies (IND, BLA, NDA, MAA)
- Manage the team to ensure the documents are of the highest quality and ensure the team has met timelines
- 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
- 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.
Bachelor's degree in a relevant life science discipline is required; an Advanced degree is preferred
- 8-10+ years of relevant medical writing industry experience in a biopharmaceutical setting
- 2+ years of experience managing medical writing teams as a Submission Lead in a pharma or biotech setting
- Authored the following Documents: IND, Patient study report/CSRs, protocols, IBs, NDA, BLA, MAA (eCTD)
- Strong FDA interactions, ICH, GCP regulations and guidelines
- Vendor management experience
- A solid understanding of the drug development process, including documents that are required at each stage and the regulatory environment, such as FDA/EMA/ICH
- Experience in autoimmune disease, Stem Cell, and Infectious disease is a plus
- Oncology experience is highly preferred but not essential
- Prior hands-on leadership and management 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 firstname.lastname@example.org or (646) 430-1191 for more information.