Associate Director, Regulatory Medical Writing - Oncology Job at ...
Johnson & Johnson Innovative Medicine - Horsham, PA, United States, 19044
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Overview
Associate Director, Regulatory Medical Writing - Oncology
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Job Overview
Johnson & Johnson is committed to health innovation, aiming to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized solutions. We are seeking a highly experienced Regulatory Medical Writer to lead and coordinate complex medical and regulatory documents, support strategic initiatives, and manage teams in our Oncology division.
Key Responsibilities
- Lead writing efforts independently for compounds and indications within oncology.
- Set and drive functional strategies and project-level tactics.
- Represent therapeutic areas at high-level meetings with some decision-making authority.
- Coordinate and write complex documents across teams, ensuring compliance with internal standards and external regulations.
- Oversee external contractors and lead process improvement initiatives.
- If managing a team, supervise, mentor, and participate in hiring and performance evaluations.
Qualifications
- Bachelor’s degree in a scientific discipline; advanced degrees preferred.
- Minimum of 10 years of pharmaceutical/scientific experience, including 8 years of medical writing in a regulatory context.
- Proven project management and process improvement skills.
- Strong leadership, communication, and problem-solving skills.
- Experience managing teams and coordinating across functions is preferred.
Additional Information
This role offers a hybrid or remote work arrangement, with locations in the US and other countries. Compensation includes a competitive salary, bonuses, and comprehensive benefits. Johnson & Johnson is an Equal Opportunity Employer.
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