Director, Medical Writing

Johnson & Johnson Innovative Medicine

2d • $164,000 - $282,900

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine 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. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Director, Medical Writing. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-068643 Belgium & Netherlands- Requisition Number: R-070187 United Kingdom- Requisition Number: R-070197 Switzerland- Requisition Number: R-070190 Canada- Requisition Number: R-070205 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Remote work options may be considered on a case-by-case basis and if approved by the Company. 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.

Requirements

• A university/college degree in a scientific discipline is required.
• 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.
• 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.

Nice To Haves

• An advanced degree (eg, Masters, PhD, MD) is preferred.

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 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.
• 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.

Benefits

• Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.
• Bonuses are awarded at the Company’s discretion on an individual basis.
• 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.
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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 the birth/adoption/foster care of a child
• 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director