Medical Writer III, X-TA

Johnson & Johnson Co.; Leiden; Híbrido; EUR 64.000 - 103.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Leiden, Netherlands seeks a Medical Writer III, Regulatory Medical Writing, to support global regulatory documents across multiple therapeutic areas within IDAR. Hybrid model with potential multi-country postings; case-by-case remote options.

The role emphasizes leading document planning, mentorship, and cross-functional collaboration to ensure timely, compliant submissions. Requires 6+ years in pharma writing and strong English communication.

Formación

• A university/college degree in a scientific discipline is required.
• An advanced degree (eg, Masters, PhD, MD) preferred.
• At least 6 years of relevant pharmaceutical/scientific; at least 4 years of relevant medical writing experience is required.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• English fluency required.
• Attention to detail.
• Able to function in a team environment.
• Strong project/time management skills.
• Strong project/process leadership skills.
• Able to resolve complex problems under supervision.Demonstrate learning agility.
• Able to build solid and productive relationships with cross-functional team members.

Responsabilidades

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional document planning and review meetings. Interacting with cross-functional colleagues on document content and acting as a champion of medical writing processes and best practices.
• Will function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
• Will be primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coach or mentor of more junior staff on document planning, processes, and content.
• Active participant in or lead of process working groups.

Conocimientos

Medical Writing

Regulatory Writing

Cross-functional collaboration

Project management

Communication

Team collaboration

Attention to detail

Problem solving

Educación

Bachelor's degree in a scientific discipline

Advanced degree preferred (Masters/PhD/MD)

Descripción del empleo

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:

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

Job Description:

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 a Medical Writer III, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located Maidenhead, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; or Beerse, Belgium.

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.

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-103733
Belgium/Netherlands/France/Germany - Requisition Number: R-104917

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

Are you ready to join our team? Then please read further!

You will be responsible for:

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional (eg, with clinical team) document planning and review meetings. Interacting with cross-functional colleagues on document content and acting as a champion of medical writing processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• Will function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision. Will be primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coach or mentor of more junior staff on document planning, processes, and content. Provides peer review as needed.
• Active participant in or lead of process working groups.

Qualifications / Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) preferred.
• At least 6 years of relevant pharmaceutical/scientific; at least 4 years of relevant medical writing experience is required.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• English fluency required.
• Attention to detail.
• Able to function in a team environment.
• Strong project/time management skills.
• Strong project/process leadership skills.
• Able to resolve complex problems under supervision.Demonstrate learning agility.
• Able to build solid and productive relationships with cross-functional team members.

Benefits

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affimative 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

• The Netherlands: The anticipated base pay range for this position is 64,000 – 103,040 Euro.
• Belgium: The anticipated base pay range for this position is 72,500 – 115,230 Euro.
• France: The anticipated base pay range for this position is 53,500 – 85,790 Euro.
• Germany: The anticipated base pay range for this position is 75,000- 118,450 Euro.

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Required Skills:

Medical Writing, Project Management, Regulatory Writing

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)

The anticipated pay ranges for additional locations are:

• The Netherlands: The anticipated base pay range for this position is 64,000 – 103,040 Euro.
• Belgium: The anticipated base pay range for this position is 72,500 – 115,230 Euro.
• France: The anticipated base pay range for this position is 53,500 – 85,790 Euro.
• Germany: The anticipated base pay range for this position is 75,000- 118,450 Euro.

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.