Senior Manager/Associate Director, Regulatory Medical Writing X-TA

Job title:

Senior Manager/Associate Director, Regulatory Medical Writing X-TA

Company

Johnson & Johnson

Job 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.comJob Function:
Medical Affairs GroupJob Sub Function:
Medical WritingJob Category:
People LeaderAll Job Posting Locations:
Beerse, Antwerp, Belgium, Leiden, South Holland, NetherlandsJob Description:Senior Manager/Associate Director, Regulatory Medical Writing X-TAAt 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-medicineWe 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 one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) 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.Are you ready to join our team? Then please read further!You will be responsible for:

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

• May have additional major responsibility with supervision.

• Cross-functional, cross-TA, or cross-J&J initiative/collaboration.

• Larger organizational responsibility (eg, manage a subset of TA).

• Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.

• Leading program-level/submission writing teams independently.

• Directly leading or setting objectives for others on team projects and tasks.

• Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.

• Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.

• Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups.

• Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.

• If a lead writer for a program:

• Primary point of contact and champion for Medical Writing activities for the clinical team.

• Responsible for planning and leading the writing group for assigned program.

• Able to function as a lead writer on any compound independently.

• Leading discussions in Medical Writing and cross‐functional meetings as appropriate.

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

• Able to oversee the work of external contractors.

• As a people manager:

• Manage direct reports in Medical Writing.

• Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.

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

• Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.

Qualifications /Requirements:

• University/college degree in a scientific discipline is required. Masters or PhD preferred.

• At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!

• At least 2 years of people management experience.

• Multiple therapeutic area experience preferred.

• Strong attention to detail.

• Strong oral and written communication skills. Fluent written and spoken English.

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

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

• Ability to delegate responsibility to junior writers.

• Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.

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

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-027208
+ Belgium, Netherlands – Requisition Number: R-028681
+ Switzerland – Requisition Number: R-028682
+ United States – Requisition Number: R-028683

• 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 yearFor additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThe 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.#LI-Hybrid#LI-Remote

Expected salary

Location

Beerse, Antwerpen

Job date

Mon, 18 Aug 2025 22:08:55 GMT

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