Manager, Medical Writing - Permanent - Hybrid
Proclinical is seeking a Manager, Medical Writing to join a global biopharmaceutical company. This is a permanent role with the opportunity to work hybrid in Bridgewater, NJ.
Primary Responsibilities
In this role, you will support the authoring and development of documentation required for regulatory submissions based on scientific knowledge and applicable global regulatory guidance as well as legislation through all phases of development and post-approval across global markets. The position is hybrid (2-3 days per week in-office) at their New Jersey site.
Skills & Requirements:
- Advanced scientific degree in a life sciences or technical field from an accredited university.
- 5+ years related experience in medical writing for regulatory submissions.
- Rare disease or specialty pharmaceutical experience preferred.
- Must be eligible to work in the US.
The Manager, Medical Writing will:
- Responsible for the authoring, editing, and finalization/approval of medical writing deliverables intended for final disposition to Health Authorities in support of regulatory submissions.
- Has an in-depth understanding of complex scientific information and development data to expertly author documentation clearly, including incorporating key messaging.
- Develops authoring timelines aligned to company strategic goals, including key regulatory milestones and activities.
- Acts as medical writing subject matter expert on cross-functional teams to provide guidance and recommendations on document authoring activities.
- Contributes to submissions, including Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), regulatory meeting documents, registration filings, and supplements/ amendments thereof, as well as abstracts, publications, and/or presentations.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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