Regulatory Medical Writing Manager, XTA – Hybrid

Johnson And Johnson; High Wycombe; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

Johnson & Johnson in High Wycombe, UK is seeking a Manager, Regulatory Medical Writing to lead cross-functional teams across therapeutic areas. You will prepare and finalize clinical documents, drive regulatory writing strategy, and manage submission activities in a hybrid environment.

The role requires 8+ years in pharma, strong English communication, and the ability to guide junior writers; Masters or PhD preferred. Hybrid work arrangement with onsite expectations.

Qualifications

• University/college degree required; Masters or PhD preferred.
• At least 8 years of pharmaceutical/scientific experience; at least 6 years of medical writing experience.
• Submission leadership experience preferred.
• English fluency; excellent oral and written communication.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment with independence and lead role on projects and content strategy.
• Lead or set objectives for others on team projects and tasks; guide process working groups.
• Coach cross-functional team members on processes and best practices; mentor junior staff.
• Represent Medical Writing in industry standards working groups; manage cross-functional meetings.

Skills

Medical Writing

Regulatory Writing

Submission Management

Coaching

Cross-functional collaboration

Data Synthesis

Education

Masters or PhD preferred

Bachelor's degree required

Job description

Johnson & Johnson in High Wycombe, UK is seeking a Manager, Regulatory Medical Writing to lead cross-functional teams across therapeutic areas. You will prepare and finalize clinical documents, drive regulatory writing strategy, and manage submission activities in a hybrid environment.

The role requires 8+ years in pharma, strong English communication, and the ability to guide junior writers; Masters or PhD preferred. Hybrid work arrangement with onsite expectations.