Analyst II, Regulatory Medical Writing X-TA

Johnson & Johnson

  • High Wycombe, Buckinghamshire
  • Permanent
  • Full-time
  • 6 days ago
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.comJob Function: Medical Affairs GroupJob Sub Function: Medical WritingJob Category: ProfessionalAll Job Posting Locations: High Wycombe, Buckinghamshire, United KingdomJob Description:Analyst II, Regulatory Medical Writing X-TAOur 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 atWe are searching for the best talent for Analyst II, Regulatory Medical Writing, X-TA 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 or Beerse, Belgium. The position is hybrid (3 days onsite weekly). Remote work options including from other EU countries may be considered on a case-by-case basis and if approved by the company.As Analyst II, Regulatory Medical Writing X-TA, you will support across 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 of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):Are you ready to join our team? Then please read further!Purpose:
  • Develop within the medical writing role within the pharmaceutical industry.
  • Work in a team environment and matrix.
  • Gain knowledge and apply internal standards, regulatory, and publishing guidelines.
  • Learn and use internal systems, tools, and processes.
  • Write and coordinate basic documents and help to prepare more complex documents.
  • Perform routine tasks per established procedures.
You will be responsible for:
  • Write and coordinate clinical documents such as protocols, clinical study reports, tables of studies, narratives, and investigator’s brochures with oversight.
  • Perform document QC, literature searches, and other tasks.
  • Work in a matrix environment and gain an understanding of the medical writing responsibilities on project teams.
  • Partner with experienced colleagues on document planning, timelines, and content development according to internal processes.
  • Participate in or lead cross-functional document planning and review meetings independently or with oversight.
  • May participate in initiatives to improve medical writing processes and standards.
  • Acquire, maintain, and apply knowledge of industry, company, and regulatory guidelines.
  • Regularly meet with manager and mentors and attend departmental meetings.
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.
  • Strong oral and written communication skills in English.
  • Ability to understand, interpret, and summarize scientific or medical data.
  • Ability to function in a team environment and to build solid and positive relationships with cross‐functional team members.
  • Demonstrated problem-solving skills.
  • Strong attention to detail.
  • Strong time management and project/process management skills.
  • Demonstrated learning agility.
  • Sound knowledge of Microsoft Office programs (eg, Microsoft Word, Excel, PowerPoint, Outlook).
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-028462
  • Netherlands, Belgium- Requisition Number: R-030654
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.BenefitsWe 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:All qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations.#LI-Hybrid#LI-Remote

Johnson & Johnson