Job Overview
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.
Job Details
Job Function: Medical Affairs Group
Job Sub Function: Medical Writing
Job Category: People Leader
Locations
Allschwil, Switzerland; Beerse, Antwerp, Belgium; High Wycombe, Buckinghamshire, United Kingdom; Leiden, Netherlands; Raritan, New Jersey, USA; Spring House, PA, USA; Titusville, NJ, USA; Toronto, Ontario, Canada
Purpose
The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). The role functions as a primary liaison with cross‑functional teams, drives strategic discussions, develops internal medical writers, and ensures adherence to best practices and regulatory guidelines. The Director of RegMW has the authority to oversee projects, identify risks, and implement process improvements while managing internal teams and contributing to organizational initiatives.
Responsibilities
* Assume overall accountability for decision‑making within the organization or TA, ensuring alignment with strategic goals
* Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles
* Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions
* Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence
* Represent the MW department with decision‑making authority in the R&D organization, leading discussions with senior cross‑functional colleagues and external partners to enhance coordination between departments
* Directly lead or set objectives for team projects and tasks, including leading program‑level, submission, indication, and disease area writing teams independently
* Serve as a liaison between team members and senior leadership within a TA or sub‑function, facilitating effective communication and collaboration
* Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross‑functional team members
* Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed
* Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems
* Participate in industry standards working groups to represent MW and ensure alignment with best practices
* Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU)
* Head and in line with R&D priorities and TA objectives
* Recognized expert medical writer for any document within and across TAs
* Accountable for MW resource management and allocation within their portfolio(s)
* Can represent MW DU Head or department at high‑level and cross‑functional TA meetings and has significant independent decision‑making authority
* Can step in for DU Head in case of absence
* Is a major contributor to multiple deliverables for the function, TA, or DU
* Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication
* Responsible for creating an environment where employees feel engaged and empowered, and take pride in their role, responsibilities, and deliverables
* Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality
o Cross‑functional, cross‑TA, cross‑J&J initiative/collaboration
o Larger organizational responsibility (e.g., manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization
* Supervises/manages and is accountable for direct reports
* Sets objectives and agrees on goals for direct reports; provides performance oversight, including providing feedback on performance and development
* Regularly meets 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
* Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal‑setting, end‑of‑year performance reviews, and compensation planning
* If applicable, frequent engagement with staff and leading discussions on employee development and talent management
Qualifications / Requirements
* A university/college degree in a scientific discipline is required; an advanced degree (e.g., Masters, PhD, MD) is preferred
* Minimum of 14 years of relevant pharmaceutical/scientific experience is required
* Minimum of 12 years of relevant clinical/medical writing experience is required
* Minimum of 5 years of people management experience is required
* Expertise in project management and process improvement is required
* Strong decision‑making skills, strategic thinking, agility, and broad vision is required
Other Competencies
* Excellent oral and written communication skills
* Attention to detail
* Expert time management for self, direct reports (if applicable), and teams
* Ability to delegate responsibility to other medical writers
* Expert ability to lead and influence by example and stay focused (positive) and demonstrate integrity
* Expert ability to motivate and develop best‑in‑class talent pipeline
* Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers
* Creates a positive Credo‑based work environment for staff members
* Shows openness to new ideas and fosters organizational learning
Compensation
The expected pay range for this position is $160,000 to $276,000. The position is eligible for an annual performance bonus in accordance with the applicable plan.
Benefits
* Medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance
* Consolidated retirement plan (pension) and savings plan (401(k))
* Long‑term incentive program
* Time‑off benefits:
o Vacation – 120 hours per calendar year
o Sick time – 40 hours per calendar year (48 hours for Colorado, 56 hours for Washington)
o Holiday pay, including floating holidays – 13 days per calendar year
o Work, personal and family time – up to 40 hours per calendar year
o Parental leave – 480 hours within one year of birth/adoption/foster care of a child
o Bereavement leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
o Caregiver leave – 80 hours in a 52‑week rolling period
o Volunteer leave – 32 hours per calendar year
o Military spouse time‑off – 80 hours per calendar year
Closing Date
This job posting is anticipated to close on October 31, 2025. The Company may however extend this time‑period, in which case the posting will remain available to accept additional applications.
Equal Opportunity Statement
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 via or contact AskGS to be directed to your accommodation resource.
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