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, United States; Spring House, Pennsylvania, United States; Titusville, New Jersey, United States; 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). This role is a primary liaison with cross‑functional teams, driving strategic discussions, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while working with internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA‑level strategies, lead process working groups, champion internal standards, and improve internal systems and tools.
You Will Be Responsible For
* 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.
* 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.
As Medical Writing Submission Strategist (MWSS)
* Act as the primary interface with the Compound Development Teams (CDTs) at the early stages of submission preparation and as a MW expert for the delivery of Johnson & Johnson Innovative Medicine marketing applications.
* Bring scientific and regulatory submissions expertise to the clinical components of marketing applications, across all TAs.
* Recognized as a subject‑matter expert responsible for submission strategy in support of multiple submissions across different TAs, starting with collaboration on the early draft label.
* Develop/maintain submission training materials specific to clinical content, and submission document requirements/processes, training teams as needed; and promote optimized planning, execution, and delivery of submissions.
* Support development of and team adherence to Submission Excellence best practices and drives consistency of departmental practices across R&D.
* Lead early strategic submission discussions in collaboration with key stakeholders and senior leadership, focusing on clinical scientific content.
* Hold the cross‑functional team accountable for developing the clinical storyboard document, prioritizing and making decisions on activities that impact MW deliverables.
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.
* 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
The expected pay range for this position is $164,000 to $282,900.
Benefits
* Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long‑term disability, business accident insurance, and group legal insurance.
* Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
* This position is eligible to participate in the Company’s long‑term incentive program.
* Subject to the terms of their respective policies and date of hire, employees are eligible for the following 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 the 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
* For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
EEO 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 under 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.
Closing Date
This job posting is anticipated to close on April 30, 2026.
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