Manager, Oncology Regulatory Medical Writing

TN United Kingdom; High Wycombe; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manager for Oncology Regulatory Medical Writing, based in High Wycombe. This role involves preparing clinical documents, leading teams, and ensuring compliance with regulatory guidelines. The ideal candidate will have extensive experience in medical writing, particularly in oncology, and a strong background in project management. Join a forward-thinking company that values innovation and collaboration in healthcare, where your expertise will help drive significant advancements in patient care and treatment options.

Qualifications

• 8+ years of pharmaceutical/scientific experience, with 6+ years in medical writing.
• Oncology experience preferred; strong project management skills required.

Responsibilities

• Prepare and finalize clinical documents while leading projects and teams.
• Coach junior staff and manage direct reports for professional development.

Skills

Medical Writing

Project Management

Communication Skills

Attention to Detail

Regulatory Knowledge (ICH)

Education

University/College Degree

Masters or PhD

Job description

The job description provided is comprehensive and well-structured, but it contains some formatting inconsistencies and extraneous content that could be improved for better clarity and readability. Here is a refined version:

Manager, Oncology Regulatory Medical Writing, High Wycombe

Client: Johnson and Johnson

Location: High Wycombe, United Kingdom

Job Category: -

EU work permit required: Yes

Job Reference: 3fa57613ee21

Job Views: 3

Posted: 05.05.2025

Expiry Date: 19.06.2025

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured; treatments are smarter and less invasive; and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are positioned to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow and profoundly impact health for humanity.

Johnson & Johnson Innovative Medicine focuses on treating, curing, and preventing some of the most devastating and complex diseases of our time. We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina.

Within the Integrated Data Analytics & Reporting (IDAR) team, we are recruiting a Manager for our Oncology therapeutic area. The position may be located in the UK or other European countries. Remote work options may be considered on a case-by-case basis.

Key Responsibilities:

• Prepare and finalize all types of clinical documents.
• Lead in a team environment, taking a high level of independence and leading content, scientific strategy, timing, scheduling, and tracking on assigned projects.
• Set objectives for team projects and tasks, lead process working groups, and guide or train team members on processes and best practices.
• Lead project-level/submission/indication writing teams and proactively recommend process improvements.
• Act as the primary point of contact and champion for medical writing activities for the clinical team if leading a program.
• Participate actively in medical writing and cross-functional meetings.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Coach or mentor junior staff and oversee work of other writers and contractors.
• Interact with senior colleagues to enhance coordination between departments.
• Represent the Medical Writing department in industry standards working groups.

People Management:

• Manage direct reports, set objectives, and ensure professional development.
• Make decisions on hiring, onboarding, career development, and performance management.

Qualifications:

• University/college degree required; Masters or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience, with a minimum of 6 years in medical writing.
• Oncology experience preferred.
• Attention to detail, excellent communication skills, and strong project management skills.
• Knowledge of regulatory guidance documents such as ICH.

We are committed to providing reasonable accommodations for individuals with disabilities during the application and employment process. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status.