Manager, X-TA Regulatory Medical Writing

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.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Manager, Regulatory Medical Writing to support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business. The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. 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 independently within and across therapeutic areas (TAs).
• 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. May consult with more senior colleagues on complex situations.
• Lead and actively participate in setting functional tactics/strategy as needed.
• Oversee the work of external contractors.
• 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.
• If a lead writer for a program/compound (or submissions, indications, or disease areas): act as the 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.
• Proactively provide recommendations for departmental process improvements.
• 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.
• Representing Medical Writing department in industry standards working groups if and as needed.
• Complete all time reporting, training, and metrics database updates as required in relevant company systems.
• If a people manager: Manage a team of internal medical writers (direct reports). Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions. Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. Ensures direct report’s adherence to established policies, procedural documents, and templates. Accountable for the quality of deliverables and for compliance of direct reports. Participate in resource management and hiring decisions.

Education And Experience 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!
• If a people manager, preferably up to 2 years of people management experience.

Other Requirements:

• 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.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.