Medical Writer II, X-TA

Johnson & Johnson Innovative Medicine; Leiden; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

Johnson & Johnson Innovative Medicine seeks a Medical Writer II, Regulatory Medical Writing to support multiple therapeutic areas within IDAR. The role emphasizes collaboration, writing and coordination of regulatory documents across regions, and adherence to internal standards.

The position is hybrid (3 days onsite weekly) with remote options considered case-by-case, and requires 2–4+ years in regulatory medical writing along with a scientific degree.

Qualifications

• University/college degree in a scientific discipline; advanced degree preferred.
• At least 2 years of pharmaceutical/scientific experience required.
• 2 to 4+ years of regulatory medical writing experience required.

Responsibilities

• Write and coordinate basic to intermediate regulatory documents under supervision.
• Perform document QC, manage abbreviations and references, and conduct literature searches.
• Participate in cross-functional document planning and review meetings; lead on small projects as needed.
• Establish document timelines and strategies, coordinating with managers and teams.

Skills

Regulatory medical writing

Education

Bachelor's degree in scientific discipline

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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, Leiden, 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 Medical Writer II, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located Beerse, Belgium; High Wycombe/Maidenhead, UK; Leiden, Netherlands; or Neuss, Germany. 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.

As Medical Writer II, Regulatory Medical Writing, X-TA you will support one or more of our therapeutic areas (Oncology, Immunology, Neuroscience, Cardiopulmonary, Specialty Ophthalmology) within our Regulatory Medical Writing team, to author diverse regulatory medical writing documents.

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 the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium, Germany, The Netherlands - Requisition Number: R-094247

United Kingdom- Requisition Number: R-095754

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

Purpose:

• Develops within the medical writing role within the pharmaceutical industry.
• Works in a team environment and matrix.
• Performs routine tasks per established procedures.
• Gains knowledge and applies internal standards, regulatory, and publishing guidelines.
• With increasing skill, uses internal systems, tools, and processes.
• Writes and coordinates basic documents, preparing more complex documents (within the TA and across TAs) in accordance with experience level.
• Functions as a lead writer on a project, indication, or a compound either early- or late-stage in life cycle under close supervision.
• Participates in process working groups.

You Will Be Responsible For:

• Writing and coordinating basic clinical documents such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writing, contributing to, and/or coordinating low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Performing document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participating in and may be leading cross-functional document planning and review meetings. Working in a team environment with some guidance while increasing independence for longer-term activities.
• Taking an active role on assigned projects with respect to timing, scheduling, and tracking.
• 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.

In Accordance With Experience Level:

• Guiding or training cross-functional team members on processes and best practices.
• Leading early- or late-stage compound writing teams with supervision, as required.
• Learning and adhering to SOPs, templates, best practices, policies, Medical Writing Style Guide.
• Regularly meeting with manager and mentors and attending departmental meetings.
• Attending cross-functional meetings as appropriate (eg, project kick-off and review meetings, study team meetings, Global Program Team meetings).
• Completing all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintaining and applying knowledge of industry, company, and regulatory guidelines.
• Mentoring more junior staff on document planning, processes, content, or provide peer review.

Principal Relationships:

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

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

Qualifications / Requirements:

• A university/college degree in a scientific discipline is the minimum requirement, with an advanced degree (eg, Master’s degree, PhD, MD) preferred.
• At least 2 years of relevant pharmaceutical/scientific experience is required!
• A range of 2 to 4+ years of regulatory medical writing experience is required
• Strong oral and