Director, Regulatory Medical Writing (1 of 4) - Johnson and Johnson

Johnson & Johnson is currently seeking a Director, Regulatory Medical Writing. The primary location for this position is the United States. Secondary locations are Canada, United Kingdom, Switzerland, Netherlands, Belgium, Germany, Spain and France. This is a global role and is open to other countries. Remote work options may be considered on a case-by-case basis and if approved by the company.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Director, Regulatory Medical Writing (RegMW) is a highly experienced medical writer and influential leader with strategic responsibilities as it relates to the delivery of high-quality regulatory documentation. This position will focus on submission strategies across multiple therapeutic areas (TAs) and is an individual contributor role. The submission strategist is the primary RegMW interface to the Compound Development Teams (CDTs) at the early stages of submission preparation and the RegMW expert for the delivery of Johnson & Johnson Innovative Medicine marketing applications.

The scope of the role begins with collaboration on the early draft label to aid in early planning and influence submission teams. This individual will be responsible for long-term planning and translating the strategy into integrated plans for submission clinical components. This includes partnering with the team to ensure all critical interdependencies are integrated into a cohesive, cross-functional timeline with a credible critical path.

The submission strategist will develop and maintain submission training materials specific to clinical content, training teams as needed; and promotes optimized planning, execution, and delivery of submissions. Collaborate with CDTs, TAs, Submission Program Management Leaders (SPMLs), Functional Leadership (including RegMW area leads/Disease Area Stronghold (DAS) leads), Medical Writing Program Leads (MWL)/RegMW submission leads/RegMW Communities of Practice, and others to gain alignment. Support development of and team adherence to label-driven submission best practices and drive consistency of RegMW practices across R&D.

Principal Responsibilities:

Leadership:

• With a focus on clinical scientific content, lead early strategic submission discussions in collaboration with Key Stakeholders and Senior Leadership that are grounded in "Label as Driver".
• Lead and hold the cross-functional team accountable the development of the clinical storyboard document (e.g., supporting key message alignment and data pooling strategies, limitations/mitigations); lead prioritization of/decision making on activities that impact RegMW deliverables.

Advising/Influencing:

• Mentor, support, and coach RegMW submission leads, MWs, and team members, as needed.
• Support upkeep and evolution of submission templates, job aids, and training materials in collaboration with relevant RegMW Communities of Practice and Business Process Owners.
• Communicate RegMW critical path activities throughout submission delivery as needed.
• Advocate for lean writing and strategic reviews:
  • Promote development of robust RegMW document shells.
  • Promote lean authoring and strategic review principles.
• Identify/provide team training as needed.

Collaborating:

• Collaborate with CDT to develop/align on submission strategy and scope, and gain alignment on submission goals with Senior Leadership.
• Connect with key stakeholders and hold them accountable to ensure robust source documentation is developed and aligned in advance of submission strategy development (i.e. Submission Foundation Document, Draft Target Label, Target Product Profile, Compound Development Plan, and Regulatory Strategy Plan) through active participation at relevant meetings (e.g., Labeling Working Group, Regulatory Strategy meetings, Functional Team Meetings with SPML).
• Contribute to the development of the draft label, Target Product Profile, Compound Development Plan, and Regulatory Strategy plan.
• Transition near-execution phase responsibilities to the submission lead MW, as needed.

Innovating:

• Promote consistency and standardization of RegMW submission best practices across all submissions and TAs.
• Develop and continually evolve training resources.
• Provide clarity in team roles, responsibilities, and accountabilities (including contribution to development of reviewer matrix in collaboration with SPML).
• Ensure incorporation of all applicable organizational best practices, functional area input, and team commitment to delivery timing and quality.
• Develop an optimal resourcing strategy for the submission, leveraging the internal medical writing team and external partner options, as appropriate.
• Drive rapid and informed decision making.
• Challenge status quo and foster impactful innovation.
• Lead ongoing assessment of submission health and communicate operational submission metrics to measure performance and drive meaningful action.
• Perform ongoing critical path analysis to continuously drive efforts to uncover and exploit new opportunities to de-risk, accelerate, and increase overall probability of success.

Risk Management:

• Actively identify risks and contribute to risk mitigation discussions, providing leadership in scenario analysis/contingency planning for the RegMW aspects of the submission including ongoing opportunity, risk and recovery (issue) analysis.
  • Develop risk mitigation plans for all "impactful" RegMW risks to the integrated submission plan, including clearly defined risk triggers and owners.
  • Communicate RegMW mitigation strategies and escalate RegMW submission-related risks as needed to CDT, RegMW management, Key Stakeholders, and Senior Leadership.

• A minimum of a Bachelor's or equivalent University/College degree is required. Advanced degree (Masters, PhD, MD) preferred.
• A minimum of 12 years of relevant pharmaceutical/scientific experience is required.
• A minimum of 10 years of relevant medical writing experience is required.
• A minimum of 5 years of submission experience across multiple new molecular entities is required.
• Extensive understanding and experience leading teams through delivery of clinical Module 2 and Module 5 documents is required.
• Experience with Module 1 (risk management plan, assessment aid) documents is preferred.
• Knowledge of global regulations, regulatory timelines, guidelines, and regulatory requirements related to marketing applications is required.
• Knowledge of the clinical end-to-end drug development process is required.
• Strong content awareness and understanding of Regulatory Medical Writing interdependencies between all major documents of electronic Common Technical Document (eCTD) is required.
• Experience conducting Regulatory Medical Writing business process, scenario, and critical path analysis on complex projects with accelerated timelines is required.
• Experience in working with medical writing service providers (i.e. Contract Research Organizations (CROs)) in delivering relevant submission documents is required.
• Experience leading and managing Regulatory Medical Writing submissions (major global marketing applications) in a matrixed setting, including working with external partners, is required.
• Green Belt Certification or process improvement experience is preferred.
• Must have effective, oral and written and cross-cultural communication skills.
• Must demonstrate decisiveness and have the ability to resolve controversy, motivate/inspire and influence teams without formal authority.
• Must demonstrate organizational awareness, strategic thinking/agility and innovation skills.
• The ability to drive and expedite team decision-making and translate Regulatory Medical Writing strategy into a clear, executable action plan is required.
• The ability to drive decision-making with all levels regarding Regulatory Medical Writing submission strategy and deliverables and represent project teams with senior leadership and governance bodies is required.
• This position will require up to 10% travel.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $193,000 to $312,110.

The anticipated base pay range for this position in all other U.S. locations is $157,000 to $271,400.

The Company maintains highly competitive, performance-based compensation programs. 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.

Employees and/or eligible dependents may be 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.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on September 30, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.