Role: Associate Director of Clinical Regulatory Writing
Duration: 12 months
As an Associate Director of Clinical Regulatory Writing, you'll be at the forefront of driving strategic communication excellence to achieve successful submissions and approvals. Our team provides expert communications leadership to drug projects, crafting clinical‑regulatory documents that align with project strategies and regulatory requirements. You'll be engaged in multiple high‑priority programs, acting as both a leader and coach, advocating for the team and fostering an environment of productivity and engagement. Your role will involve developing communication strategies and optimizing document delivery within CVRM across all phases of clinical development.
Accountability
- Provide expert leadership for submissions or programs, overseeing the communication strategy.
- Lead submission activities and author documents within a program, including health authority responses.
- Review key submission documents for consistency of messaging.
- Influence stakeholders at the highest levels of the organization to establish best communications practices.
- Drive resourcing strategy within area of accountability.
- Develop and embed innovative best practices, tools, and processes that elevate quality, speed, and impact.
Essential skills/experience
- Bachelor’s degree in Life Sciences or related discipline, PhD is strongly preferred.
- Significant experience in medical/regulatory writing within pharmaceutical/biotech or CRO environments.
- Proven ability to advise on and lead complex communication programs and submission teams.
- Strong understanding of drug development and the end‑to‑end communications process from early development through launch and lifecycle management.
- In‑depth knowledge of relevant technical and regulatory requirements; track record of delivering high‑quality, label‑focused documents under tight timelines.
- Advanced scientific degree (e.g., PhD).
You’ll influence pivotal regulatory outcomes for programs that address some of the world’s most prevalent diseases. You’ll lead at scale, shape standards, and grow future leaders, while collaborating with world‑class cross‑functional teams committed to scientific excellence and patient impact.
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