Jobid: 3195967907 (0.11)
Overview
In this role you will lead regulatory medical writing for Immunology, ensuring high-quality clinical documentation and strategic alignment with regulatory expectations. You will manage and mentor a writing team, guiding content, timing, and cross-functional coordination. You will drive process improvements and represent Medical Writing in cross-functional and industry activities. This role helps accelerate immunology programs from clinical data to compliant submissions, partnering with the broader IDAR organization. A focus on collaboration and scientific rigor underpins your impact.
Arbeidsvoorwaarden / Benefits
- annual bonus with target % of pay
- vacation days
- parental leave (min 12 weeks)
- bereavement leave
- caregiver leave
- well-being reimbursement
Verantwoordelijkheden
- Prepare and finalize all types of clinical documents
- Lead in a team environment and take a lead role on assigned projects
- Set objectives for others on team projects and lead process working groups
- Coach or mentor junior staff and oversee work of writers and contractors
- May lead project-level submission teams and indicate with scientific strategy
- Provide recommendations for departmental process improvements
- Act as primary point of contact for medical writing activities for the clinical team
- Plan and lead the writing group for assigned programs
- Participate in medical writing and cross-functional meetings
- Maintain knowledge of regulatory guidelines and industry trends
- Interact with senior colleagues to strengthen cross-functional coordination
- May represent Medical Writing in industry standards groups
- Manage direct reports and set development and performance objectives
- Make hiring and talent development decisions and manage performance discussions
Belangrijkste vereisten
- University/college degree required; Masters or PhD preferred
- At least 8 years of pharmaceutical/scientific experience; at least 6 years in medical writing
- 2 years of people management experience preferred
- Strong attention to detail and communication skills
- Excellent oral and written communication for cross-functional discussions
- Expert project/time management and leadership abilities
- Ability to interpret and present statistical and medical information accurately
- Independent problem-solving and learning agility
- Solid knowledge of regulatory guidance documents such as ICH
- Cross-functional collaboration
- Developing others / coaching
- Inclusive leadership
- Regulatory medical writing
- Clinical research and regulations
- SOP and process leadership
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