Manager Medical Writing XTA
About The Position
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. We are searching for the best talent for a Manager, 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; 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 and if approved by the company).
Requirements
- University/college degree required. Masters or PhD preferred.
- At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
- Submission leadership experience preferred.
- Experience of multiple therapeutic areas preferred.
- Attention to detail.
- Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
- Expert project/time management skills.
- Strong project/process leadership skills.
- Ability to recognize how to best 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.
Nice To Haves
- Submission leadership experience
- Experience of multiple therapeutic areas
Responsibilities
- Preparing and finalizing all types of clinical documents.
- Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
- Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
- Guiding or training cross-functional team members on processes and best practices.
- Potentially leading project-level/submission/indication writing teams.
- Proactively providing recommendations for departmental process improvements.
- If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
- Actively participating in medical writing and cross-functional meetings.
- Maintaining knowledge of industry, company, and regulatory guidelines.
- Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed; overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
- Interacting with senior cross-functional colleagues to strengthen coordination between departments.
- May be representing Medical Writing department in industry standards working groups.
Benefits
- Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- 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; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Manager
