Manager Medical Writing XTA

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.

About the role

We are searching for a Manager, Regulatory Medical Writing to support across key therapeutic areas within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located in High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; Beerse, Belgium; or Horsham / Spring House / Raritan, United States. The position is hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment with a high level of independence, taking a lead role on assigned projects regarding content, scientific strategy, timing, scheduling, and tracking.
• Lead or set objectives for others on team projects and tasks, e.g., leading process working groups.
• Guide or train cross-functional team members on processes and best practices.
• Potentially lead project-level/submission/indication writing teams.
• Proactively provide recommendations for departmental process improvements.
• If a lead writer for a program: act as the primary point of contact and champion for medical writing activities for the clinical team, responsible for planning and leading the writing group for the assigned program.
• Actively participate in medical writing and cross-functional meetings.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Coach or mentor more junior staff on document planning, processes, content, and provide peer review as needed; oversee the work of other medical writers, external contractors, and document specialists supporting a project.
• Interact with senior cross-functional colleagues to strengthen coordination between departments.
• May represent the Medical Writing department in industry standards working groups.

Requirements

• University/college degree required; Master's or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience.
• Submission leadership experience preferred.
• Experience in multiple therapeutic areas preferred.
• Attention to detail.
• Excellent oral and written communication skills, with fluency in English.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross-functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.
• Ability to commute to site.

Benefits

• Annual base pay range: $117,000 - $201,250 USD (1.0 FTE basis).
• Eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Vacation: up to 120 hours per calendar year.
• Sick time: up to 40 hours per calendar year (up to 56 hours for employees residing in Washington State).
• Holiday pay, including Floating Holidays: up to 13 days per calendar year.
• Work, Personal, and Family Time: up to 40 hours per calendar year.

Skills

• Required: Medical Writing, Regulatory Writing, Submission Management
• Preferred: Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Process Improvements, Proofreading, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility