Senior Analyst Regulatory Medical Writing, Immunology

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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Leiden, South Holland, Netherlands, Neuss, North Rhine-Westphalia, Germany

Job Description:

Senior Analyst Regulatory Medical Writing, Immunology

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 Analyst Regulatory Medical Writing, within Integrated Data Analytics & Reporting (IDAR), to join our diverse team of medical writers for immunology indications. The role can be located High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands; or Neuss, Germany. Hybrid working is expected for applicants living within commutable distance of a J&J office (3 days onsite per week). Remote work options may be considered on a case-by-case basis for those outside tenable commutable area, and if approved by the company.

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 document planning and review meetings. Interacting with cross-functional colleagues on document content and champions MW 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.
• Actively participating in or leading process working groups.
• Coaching or mentoring more junior staff on document planning, processes, and content. Provides peer review as needed.

Principal Relationships:

• Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents.
• External: May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.

Qualifications / Requirements:

• A university/college degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
• At least 6 years of relevant pharmaceutical/scientific experience including at least 4 years of regulatory medical writing experience is required.

Other:

• Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in all document types under general supervision.
• Proficiency in written and spoken English is essential, together with excellent oral and written communication skills.
• Strong attention to detail.
• Ability to collaborate with cross-functional global teams across time zones, requiring some flexibility in your daily routine.
• Builds productive relationships with cross-functional team members.
• Has strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
• Organizes time well, and demonstrates learning agility.

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):

• Belgium, Netherlands, Germany: R-037404
• United Kingdom- Requisition Number: R-036329

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

Benefits:

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The Johnson & Johnson Family of Companies maintain highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. Bonuses are awarded at the Company's discretion on an individual basis.

The employee will be eligible to participate in the Company sponsored employee benefit programs applicable to the country in which they are based. These may include medical, dental, vision, life insurance, short- and long-term disability, accident insurance, and group legal insurance.

Employees may be eligible to join in the Company’s retirement plan (pension) or savings plan.

#LI-Hybrid