Analyst II, Regulatory Medical Writing X-TA
- High Wycombe, Buckinghamshire
- Permanent
- Full-time
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 at https://www.jnj.com/innovative-medicineWe 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.
- 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.
- 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).
- United Kingdom - Requisition Number: R-028462
- Netherlands, Belgium- Requisition Number: R-030654
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