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. Learn more at https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

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. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Manager, Regulatory Medical Writing to support one or more of our therapeutic areas in 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

Are you ready to join our team? Then please read further!

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, eg, 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 an