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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.
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