Director, Medical Writing – Oncology (Regulatory Medical Writer)
Johnson & Johnson believes health is everything. We invest in a world where complex diseases are prevented, treated, and cured by using smarter, less invasive, and more personal solutions. Through our expertise in Innovative Medicine and MedTech, we innovate across the full spectrum of healthcare solutions, delivering breakthroughs that profoundly impact health for humanity. Learn more at https://www.jnj.com
Our purpose is to develop treatments, find cures, and pioneer the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
This role is available across multiple countries. For each country, a specific requisition number applies: United States – R-038874, Belgium & Netherlands – R-039974, United Kingdom – R-039973, Switzerland – R-039972, Canada – R-039966. We recommend applying to the posting that aligns with your preferred location, but applications to multiple posts are considered one submission.
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 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.
* 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 in line with R&D priorities and TA objectives.
o Recognized expert medical writer for any document within and across TAs.
o 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) adhere 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
* 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.
* Minimum of 12 years of relevant clinical/medical writing experience.
* Minimum of 5 years of people management experience.
* Expertise in project management and process improvement.
* Strong decision‑making skills, strategic thinking, agility, broad vision.
Other Skills & Abilities
* Excellent oral and written communication skills.
* Attention to detail.
* Expert time management for self, direct reports, and teams.
* Ability to delegate responsibility to other medical writers.
* Expert ability to lead and influence by example, stay focused, 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 $160,000 to $276,000. The position is eligible for an annual performance bonus in accordance with company policy.
Benefits include:
* 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 in Colorado, 56 hours in Washington)
o Holiday pay – 13 days per calendar year (including floating holidays)
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 (10 days)
o Volunteer leave – 32 hours per calendar year
o Military spouse time‑off – 80 hours per calendar year
Equal Employment Opportunity
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 any other characteristic 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 applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Application Closing Date
This job posting is anticipated to close on October 31, 2025. The posting may remain open if the company extends the time period.
#J-18808-Ljbffr