Job Function
Medical Affairs Group
Job Sub Function
Medical Writing
All Job Posting Locations
Allschwil, Switzerland; Beerse, Antwerp, Belgium; High Wycombe, Buckinghamshire, United Kingdom; Leiden, Netherlands; Titusville, New Jersey, United States of America; Toronto, Ontario, Canada
Purpose
The Director of Regulatory Medical Writing (RegMW) is a leader with extensive medical writing expertise across therapeutic areas. This role is the primary liaison with cross‑functional teams, drives strategic discussions, develops internal medical writers, and ensures adherence to best practices and regulatory guidelines. The director oversees projects, identifies risks, implements process improvements, and manages internal teams while contributing to organizational initiatives.
You Will Be Responsible For
* 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 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 therapeutic area 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.
Qualifications / Requirements
* A university/college degree in a scientific discipline is required. An advanced degree (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.
* Experience providing strategic and operational leadership to medical writing teams across all levels, with responsibility for setting vision, driving functional excellence, mentoring leaders, and ensuring the successful delivery of high‑quality, compliant clinical and regulatory documentation across the portfolio.
* Expertise in project management and process improvement is required.
* Strong decision‑making skills, strategic thinking, agility, broad vision is required.
Other
* 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). 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
Expected pay range: $164,000 to $282,900.
Benefits
Johnson & Johnson offers a comprehensive benefits package that includes medical, dental, vision, life insurance, short‑ and long‑term disability, retirement plans, and additional time‑off benefits. For full details, visit the company benefits website.
Equal Opportunity Employer
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.
#J-18808-Ljbffr