Manager, Regulatory Medical Writing X-TA

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.

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Issy-les-Moulineaux, France, Leiden, South Holland, Netherlands, Neuss, North Rhine-Westphalia, Germany

Job Description:

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 Manager, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; Beerse, Belgium; or Spring House or Raritan, United States. The position is Hybrid (3 days onsite weekly). 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:

• Preparing and finalizing all types of clinical documents.
• Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
• Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
• Guiding or training cross-functional team members on processes and best practices.
• Potentially leading project-level/submission/indication writing teams.
• Proactively providing recommendations for departmental process improvements.
• 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.
• Actively participating in medical writing and cross-functional meetings.
• Maintaining knowledge of industry, company, and regulatory guidelines.
• Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed; overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
• Interacting with senior cross-functional colleagues to strengthen coordination between departments.
• May be representing Medical Writing department in industry standards working groups.

Qualifications /Requirements:

• University/college degree required. Masters or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
• Experience of multiple therapeutic areas preferred.
• Attention to detail.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross‐functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.

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-044899

Netherlands, Germany, France, Belgium- Requisition Number: R-045504

United States – Requisition Number: R-059028

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

Benefits

For United States applicants only: 

The anticipated base pay range for this position is $117,000 to $201,250 (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.  

#LI-Hybrid

 

 

Required Skills:

Clinical Study Reports, Medical Writing, Project Management Leadership, Regulatory Documents

 

 

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Process Improvements, Proofreading, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility