Medical Writer III, Regulatory Medical Writing, X-TA

We are searching for the best talent for a Medical Writer III, Regulatory Medical Writing 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; Neuss, Germany; Paris, France; or Beerse, Belgium. 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.

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 (eg, with clinical team) document planning and review meetings. Interacting with cross-functional colleagues on document content and acting as a champion of medical writing 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.
• Will function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision. Will be primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coach or mentor of more junior staff on document planning, processes, and content. Provides peer review as needed.
• Active participant in or lead of process working groups.

Qualifications / Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) prefered.
• At least 6 years of relevant pharmaceutical/scientific; at least 4 years of relevant medical writing experience is required.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• English fluency required.
• Attention to detail.
• Able to function in a team environment.
• Strong project/time management skills.
• Strong project/process leadership skills.
• Able to resolve complex problems under supervision.
• Demonstrate learning agility.
• Able to build solid and productive relationships with cross-functional team members.

Required Skills:

Medical Writing, Process Leadership, Regulatory Documents

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)

Hybrid Work