Job Function: Medical Affairs Group
Job Sub Function: Medical Writing
Job Category: People Leader
All Job Posting 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
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.
Purpose
The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas. This role is a primary liaison with cross‑functional teams, driving strategic discussions, ensuring adherence to best practices and regulatory guidelines. The Director has the authority to oversee projects, identify risks, implement process improvements, and guide lead medical writers across compounds. The Director will influence TA‑level strategies, lead process working groups, champion internal standards, and improve internal systems and tools.
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.
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.
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.
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.
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 TA’s.
Recognized as a subject matter expert responsible for submission strategy in support of multiple submissions across different TA’s, 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 drive 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 (eg, 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 are 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 & Benefits
The expected pay range for this position is $164,000 to $282,900. This position is eligible for an annual performance bonus, subject to the terms of the applicable plan.
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.
Vacation – 120 hours per calendar year.
Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents.
Holiday pay, including floating holidays – 13 days per calendar year.
Work, 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 an immediate family member, 40 hours for an 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.
Closing Information
This job posting is anticipated to close on April 30, 2026. The posting may be extended; additional applications will be accepted through https://www.careers.jnj.com.
Equal Opportunity Statement
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will be considered 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.
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