Manager, Regulatory Medical Writing, X-TA in High Wycombe

Join to apply for the Manager, Regulatory Medical Writing role at Johnson & Johnson Innovative Medicine. 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, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

We are searching for the best talent for a Manager, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located in High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; or Beerse, Belgium. The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case‐by‐case basis and if approved by the company.

You Will Be Responsible For:

• Preparing and finalizing all types of clinical documents.
• Leading in a team environment, working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
• Leading or setting objectives for others on team projects and tasks, e.g., leading process working groups.
• Guiding or training cross‐functional team members on processes and best practices.
• Potentially leading project‐level/submission/indication writing teams.
• Proactively providing recommendations for departmental process improvements.
• If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
• Actively participating in medical writing and cross‐functional meetings.
• Maintaining knowledge of industry, company, and regulatory guidelines.
• Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed; overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
• Interacting with senior cross‐functional colleagues to strengthen coordination between departments.
• May be representing Medical Writing department in industry standards working groups.

Qualifications / Requirements:

• University/college degree required. Masters or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required.
• Experience of multiple therapeutic areas preferred.
• Attention to detail.
• Excellent oral and written communication skills are pivotal to engage in cross‐functional discussions. English fluency required.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross‐functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.

This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Please focus on the specific country(s) that align with your preferred location(s).

Benefits:

We offer a competitive salary and extensive benefits package. The health and well‐being of our employees is a priority; we have a flexible working environment as we value work‐life balance. We offer career development opportunities for those who want to grow and be part of our organisation.

Required Skills:

• Clinical Study Reports
• Medical Writing
• Project Team Leadership
• Regulatory Documents
• Submission Management

Preferred Skills:

• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching
• Collaborating
• Copy Editing
• Data Synthesis
• Industry Analysis
• Medical Affairs
• Medical Communications
• Process Improvements
• Proofreading
• Quality Validation
• Standard Operating Procedure (SOP)
• Tactical Planning
• Technical Credibility