Senior Medical Writer (Immunology)
Remote - East Coast, United States
Seeking an experienced and highly confident and motivated Senior Medical Writer to join a small group with a well-known and well-reputable biotech. This company is focused on developing lifesaving therapies primarily to treat complex immune deficiencies (along with other multifaceted biologics within CV metabolism and even Gene Therapy)! This company is launching new programs & I am looking for an experienced and confident Submission Medical Writing Lead to join a great team for their advanced Immunology programs. This new hire will work closely with and bring strategic expertise to the project teams and outside vendors/external contacts. This is a highly strategic position with medical writing activities for regulatory documents and all complex clinical documents.
- Provides support for the preparation of submissions for global regulatory filings, i.e.: IND, IMPD, NDA, BLA, MAA) and responsible for submission writing strategies.
- Assists in developing, compiling, producing, authoring, analyzing, and interpreting INDs and IMPD sections, briefing documents, and other documents needed to support regulatory interactions and global filings.
- Will sit in on big meetings & bring back all information to the TA Lead and team, along with strategies & execution plans.
- Develop and author clinical documents for submission to global regulatory authorities.
- 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.
- You will oversee Module 2 development and will need to write 1 of 2 Modules then outsource the rest. You'll oversee the vendors who do the rest.
- You will ensure that all regulatory submission documents are fully compliant with internal document standards.
- Work closely with the team and outside employees as well 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.
- 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.
- Bachelor's degree in a Scientific discipline required (advanced degrees are highly preferred)
- 5 years of relevant industry experience in the biopharmaceutical industry.
- Experience as a Submission Lead (CTD submissions)
- Immunology experience is required.
- Must have Global & Regional regulatory writing experience for both US and EU.
If you meet the qualifications & interested in learning more, please contact Bria Gaber at firstname.lastname@example.org for more information.