Manager, Medical Writing (Oncology)
New Jersey - United States
Seeking an experienced Medical Writing Manager to join a small group with a leading global pharma organization in NJ. This new hire will work closely with and bring 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 accuracy of all complex clinical documents.
- Provides support for the preparation of submissions for global regulatory filings, i.e.: IND, IMPD, NDA, BLA, MAA
- Assists in developing, compiling, producing, authoring, analyzing, and interpretation technical writing (from 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 submission writing strategies (BLA, NDA, MAA)
- You will support and collaborate with stakeholders globally - clinical, nonclinical/pharmacology, pharmacokinetics, biostatistics
- 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 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.
- Bachelor's degree in a Scientific discipline required (advanced degrees are highly preferred)
- 2-5 years of relevant industry experience in the pharmaceutical industry (dependent upon graduate degree)
- Experience working/leading Regulatory Submissions (CTD submissions)
- Prior medical writing experience within a pharmaceutical/biotech setting
- Oncology experience is preferred but not essential
- Global regulatory writing experience for both US and EU
If interested in learning more, please contact Bria Gaber at firstname.lastname@example.org for more information.