Medical Writer
The Role & What You Will Be Doing
The Senior Regulatory Writer is responsible for independently authoring and reviewing high-quality clinical regulatory documents that support global health authority submissions. They provide strategic and scientific input to clinical and submission teams, helping shape data presentation, regulatory positioning, and document strategy. The position collaborates extensively with cross-functional partners and manages interactions with external writing vendors to ensure timely, high-quality deliverables. Additionally, the Senior Regulatory Writer mentors junior writers and contributes to the continuous strengthening of the organization’s regulatory writing capabilities
Every day, we rise to the challenge to make a difference and here’s how the Medical Writer role will make an impact:
* Autonomously write and/or review clinical regulatory documents such as CTD Module II summaries and Clinical
* Overviews, Clinical study reports (CSRs), and other regulatory documents, as needed, such as Responses to Health
* Authority questions, Briefing books, 120-day Safety updates, Pediatric investigational plans, or Investigator brochures.
* Contribute scientifically and strategically to submission teams at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing, e.g., provide input on pooling strategy, provide content expertise and guidance on regulatory requirements.
* Contribute to the planning of data analyses and presentation for CSRs; review statistical analysis plans and related documents.
* Effectively collaborate with cross-functional stakeholders, including Clinical Sciences, Clinical Pharmacology, Biometry,
* Drug Safety, Clinical Operations, CMC and Regulatory Affairs.
* Work together with the in-house Documentation Specialist(s) to produce high-quality final documents and ensure timely delivery.
* Lead or assist with the selection and management of external regulatory writing services.
* Mentor/train less experienced writers.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
* Bachelor's degree or equivalent in Life Sciences is required and a Master’s degree is preferred.
* 5 years of experience as a regulatory/medical writer in the pharmaceutical industry across several therapeutic areas are required
* Well-developed and proven medical writing skills
* Knowledge of regulatory document requirements and guidelines
* The ability to develop and mentor more junior medical writers
* The ability to work independently and as part of a team
* The ability to work under pressure and meet challenging deadlines
* Excellent interpersonal and presentation skills
* Level of English proficiency required for this role: Advanced
* Level of physical demand essential to this role: Sedentary - Minimal handling of light materials and tools, lifting up to 10 lbs. May involve walking or standing for brief periods of time.
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