Johnson & Johnson Innovative Medicine is hiring: Director, Medical Writing in Sp

Overview

Johnson & Johnson is looking for a Director of Medical Writing to drive regulatory and clinical documentation across therapeutic areas. The role supports the Medical Affairs Group within our Innovative Medicine portfolio and is open to selected locations worldwide.

Purpose

The Director of Regulatory Medical Writing (RegMW) leads multidisciplinary teams to develop, review, and submit high‑quality clinical, regulatory, and safety documents. The incumbent acts as the primary liaison with cross‑functional stakeholders, ensuring compliance with regulatory guidelines and best practices while steering process improvements and strategic initiatives.

You Will Be Responsible For

• Provide overall accountability for decision‑making within the organization or therapeutic area, aligning with strategic goals.


• Identify potential risks, develop mitigation strategies, and enhance project outcomes.


• Resolve complex problems in development and implementation of new service offerings and deliverables.


• Guide other writers on clinical, regulatory, and safety documents, leading content and scientific strategy independently.


• Represent the medical writing department in senior R&D discussions and coordinate with external partners.


• Lead or set objectives for team projects and tasks, including program‑level and indication‑specific writing teams.


• Liaise between team members and senior leadership to facilitate effective communication.


• Develop and institutionalize departmental process improvements in partnership with relevant business process owners.


• Mentor and coach staff on document planning and content, providing peer review as needed.


• Maintain industry, company, and regulatory knowledge within company systems.


• Participate in industry standards working groups to represent medical writing and align with best practices.

As Medical Writing Submission Strategist (MWSS)

• Act as the primary interface with Compound Development Teams during early submission preparation.


• Provide scientific and regulatory expertise for clinical components of marketing applications across all therapeutic areas.


• Serve as subject‑matter expert for submission strategy, including early draft label collaboration.


• Develop and maintain submission training materials and promote consistent execution of submissions.


• Support team adherence to Submission Excellence best practices and standardize departmental processes.


• Lead strategic submission discussions with key stakeholders and senior leadership, focusing on clinical scientific content.


• Hold the cross‑functional team accountable for developing clinical storyboard documents and making decisions that impact deliverables.

Qualifications / Requirements

• University/college degree in a scientific discipline (advanced degree preferred).


• Minimum of 14 years of relevant pharmaceutical/scientific experience.


• Minimum of 12 years of clinical/medical writing experience.


• Expertise in project management and process improvement.


• Strong decision‑making, strategic thinking, agility, and broad vision.

Other

• Excellent oral and written communication skills.


• Attention to detail and expert time management.


• Ability to delegate responsibilities, lead by example, and motivate talent.


• Demonstrated ability to collaborate internally and build effective partnerships.


• Creates a positive Credo‑based work environment and fosters organizational learning.

Compensation

Base salary: $164,000 – $282,900 with annual performance bonus potential and long‑term incentive program participation.

Benefits

• Medical, dental, vision, life insurance, short‑ and long‑term disability, accident, and group legal insurance.


• Consolidated retirement plan (pension) and 401(k) savings plan.


• Long‑term incentive program eligibility.


• Paid time off:
  
  
  
  • 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.
  
  
  
  

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 by federal, state or local law.

This job posting is anticipated to close on April 30, 2026.