Senior Manager/Associate Director, Regulatory Medical Writing, Immunology

Description

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 https://www.jnj.com

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Job Description:

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

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 a Senior Manager/Associate Director , Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area.

The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).

Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.

You will be responsible for:

• Leading compound/submission/indication/disease area writing teams independently.

• Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.

• Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.

• Establishing and driving document timelines and strategies independently.

• Guiding or training cross-functional team members on processes and best practices.

• Proactively identifying and championing departmental process improvements.

• May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.

• Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).

• Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.

• Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.

As a people manager:

• Supervising/managing and being accountable for direct reports.

• Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.

• Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.

• Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.

• Ensuring direct report’s adherence to established policies, procedural documents, and templates.

• Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.

Qualifications /Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

• At least 10 years of relevant pharmaceutical/scientific experience.

• At least 8 years of relevant clinical/regulatory medical writing experience.

• At least 2 years of direct people management experience.

• Experience in project management and process improvement.

• Advanced knowledge and application of regulatory guidance such as ICH requirements

• Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.

• Resolves complex problems independently.

• Proactively identifies potential risks and develops strategies to mitigate.

• Ability to serve as the liaison between team members and senior leadership within a therapy area.

• Ability to build and maintain solid and positive relationships with cross-functional team members.

• Excellent oral and written communication skills.

• Attention to detail.

• Expert time management for self and team.

• Expert project management skills, expert project/process leadership.

• Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).

• Ability to delegate responsibility to junior writers.

• Ability to lead by example, stay focused and positive, and act with integrity.

• Ability to internalize and teach CREDO behaviours.

• Ability to act as change agent and adapt to rapidly changing organizational & business challenges.

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 Kingdom - Requisition Number: R-035253
• Belgium, Netherlands - Requisition Number: R-035805
• Switzerland - Requisition Number: R- 035807
• United States - Requisition Number: R-035808

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

For United States applicants:

The anticipated base pay range for this position is $137,000 to $235,750 (USD).

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.

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.

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