Manager, Medical Writing, Immunology

About the role

Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting a Manager, Regulatory Medical, Immunology, based in Allschwil, Switzerland. The position supports the Immunology therapeutic area and involves preparing clinical documents and leading a team of medical writers.

Key responsibilities

• Prepare and finalize all types of clinical documents.
• Lead projects with a high level of independence, covering content, scientific strategy, timing, scheduling and tracking.
• Set objectives for others on team projects and guide or train cross-functional team members on processes and best practices.
• May lead project-level, submission or indication writing teams, and act as primary point of contact for medical writing activities for the clinical team.
• Recommend process improvements and represent the Medical Writing department in industry standards working groups.
• As lead writer for a program: plan and lead the writing group, take part in medical writing and cross-functional meetings, and stay up to date on industry, company and regulatory guidelines.
• Coach or mentor junior staff, provide peer review, and may oversee external contractors and document specialists.
• Manage direct reports: set objectives, hold regular development meetings, make hiring decisions, handle onboarding, career and talent development, goal-setting and performance discussions.

Required profile

• University or college degree; Master's or PhD preferred.
• At least 8 years of relevant pharmaceutical or scientific experience.
• At least 6 years of relevant medical writing experience.
• 2 years of people management experience preferred.

Required skills

• Solid knowledge of regulatory guidance documents such as ICH requirements.
• Attention to detail, excellent oral and written communication, and expert project and time management.
• Ability to interpret, summarize and present statistical and medical information accurately, and to solve complex problems independently.
• Preferred skills listed include clinical research and regulations, clinical trials operations, copy editing, SOPs, and team management.