Associate Director, Regulatory Medical Writing, Oncology
Johnson & Johnson MedTech
High Wycombe, Buckinghamshire, United Kingdom
Fully remote
Regulatory medical writing expertise
Project and process management experience
Leadership of medical writing teams
Johnson & Johnson MedTech is seeking an Associate Director of Regulatory Medical Writing in Oncology, responsible for leading complex writing projects and managing a team of medical writers. The position emphasizes independent decision-making, cross-functional collaboration, and adherence to regulatory standards in a fully remote work environment
Job Summary
Johnson & Johnson is committed to healthcare innovation to prevent, treat, and cure complex diseases while providing an inclusive work environment that respects diversity and dignity.
The Associate Director will independently lead medical writing teams, set strategies for regulatory submissions, and champion process improvements across multiple therapeutic areas.
This role involves managing direct reports, mentoring junior staff, and collaborating with senior cross-functional colleagues and external partners to ensure high-quality deliverables.
Matching Summary
Match Score: 85
Johnson & Johnson MedTech is seeking an Associate Director of Regulatory Medical Writing in Oncology, responsible for leading complex writing projects and managing a team of medical writers. The position emphasizes independent decision-making, cross-functional collaboration, and adherence to regulatory standards in a fully remote work environment.
Skills & Requirements
Must-have
Regulatory medical writing expertise
Project and process management experience
Leadership of medical writing teams
Cross-functional team collaboration
Knowledge of ICH regulatory guidelines
Clinical and regulatory document coordination
Nice-to-have
Coaching and mentoring junior writers
Change management skills
Strong communication and negotiation
Ability to act as change agent
Experience with industry standards groups
Ability to internalize and teach company values
Key Requirements
Minimum 10 years pharmaceutical/scientific experience
At least 8 years clinical/regulatory medical writing experience