Medical Writing Leaders
New Jersey - United States
Seeking highly experienced and motivated Medical Writing Leaders (at all levels) to join a small group with a leading global pharmaceutical organization in NJ. These new hires will provide guidance, leadership and an 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. *This is a permanent position and you must be local to the New Jersey site.
- You will be responsible for leading, coordinating, compiling, and producing routine regulatory submissions/amendments
- Leads submission writing strategies (BLA, NDA, MAA)
- You will manage 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.
- 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 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 Scientific discipline required (advanced degrees are highly preferred)
- 7-10 years of relevant industry experience in a pharmaceutical industry (dependent upon graduate degree)
- Experience as a Submission Lead (CTD submissions)
- Oncology experience is preferred but not essential
- Prior hands-on Leadership and Management experience
- Regulatory writing experience for both US and EU