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:
High Wycombe, Buckinghamshire, United Kingdom

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; Neuss, Germany, or Springhouse / Raritan / Titusville, United States.

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 s...