Director of Regulatory Medical Writing (PL9). Leads cross‑functional teams across therapeutic areas, drives strategy and ensures regulatory compliance for clinical, safety, and regulatory documents. Oversees project execution, identifies risks, implements process improvements, and mentors writing staff. Works from a hybrid work environment.
Key Responsibilities- Assume overall accountability for decision-making within the organization or therapeutic area, ensuring alignment with strategic goals.
- Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes.
- Resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions.
- Provide guidance to other writers on all types of clinical, regulatory, and safety documents, leading content strategy with independence.
- Represent the Medical Writing department with decision‑making authority in R&D, leading discussions with senior cross‑functional colleagues and external partners.
- Lead or set objectives for team projects and tasks, including program‑level and disease‑area writing teams.
- Serve as a liaison between team members and senior leadership within a therapeutic area or sub‑function, facilitating communication.
- Develop, implement, and drive institutionalization of departmental process improvements and best practices.
- Mentor, support, and coach staff at all levels on document planning, processes, and content.
- Maintain and disseminate knowledge of industry, company, and regulatory guidelines.
- Participate in industry standards working groups to represent Medical Writing and ensure alignment with best practices.
- Primary interface with Compound Development Teams at early stages of submission preparation.
- Apply scientific and regulatory submissions expertise to clinical components of marketing applications across all therapeutic areas.
- Lead collaborative early draft label development and support multiple submissions across therapeutic areas.
- Develop and maintain submission training materials specific to clinical content, and train teams as needed.
- Advance Submission Excellence best practices and drive consistency of departmental practices.
- Lead early strategic submission discussions with key stakeholders and senior leadership.
- Hold the cross‑functional team accountable for developing the clinical storyboard document and making decisions affecting Medical Writing deliverables.
- University/college degree in a scientific discipline (advanced degree preferred).
- Minimum of 14 years of relevant pharmaceutical or scientific experience.
- Minimum of 12 years of clinical or medical writing experience.
- Expertise in project management and process improvement.
- Strong decision‑making skills, strategic thinking, agility, and broad vision.
- Business Writing
- Clinical Research and Regulations
- Clinical Trials Operations
- Copy Editing
- Cross‑Functional Collaboration
- Developing Others
- Inclusive Leadership
- Industry Analysis
- Leadership
- Medical Affairs
- Medical Communications
- Performance Measurement
- Quality Validation
- Standard Operating Procedure (SOP)
- Succession Planning
- Tactical Planning
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us to be directed to your accommodation resource.
Benefits- Competitive salary range: $164,000 - $282,900
- Annual performance bonus (subject to plan)
- Medical, dental, vision, life insurance, short and long‑term disability, accident insurance, and group legal insurance
- 401(k) retirement plan with company match
- Long‑term incentive program
- Vacation: 120 hours per calendar year
- Sick time: 40 hours per calendar year (48 hours for Colorado, 56 hours for Washington residents)
- Holiday pay: 13 days per calendar year, including floating holidays
- Personal and family time: up to 40 hours per calendar year
- Parental leave: 480 hours within one year of birth/adoption/foster care
- Bereavement leave: 240 hours for immediate family member, 40 hours for extended family member per calendar year
- Caregiver leave: 80 hours in a 52‑week rolling period
- Volunteer leave: 32 hours per calendar year
- Military spouse time‑off: 80 hours per calendar year
€139741 - €241053 monthly