Job Description

At [Employer hidden — sign up to reveal], we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Guided by Our Credo, we provide an inclusive work environment where each person is considered as an individual.

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.

Key Responsibilities

• Preparing and finalizing all types of clinical documents.
• Leading in a team environment with a high level of independence.
• Setting objectives for others on team projects and tasks.
• Guiding cross-functional team members on processes and best practices.
• Potentially leading project-level/submission/indication writing teams.
• Proactively recommending departmental process improvements.
• Acting as primary point of contact for medical writing activities for assigned programs.
• Coaching or mentoring more junior staff.
• Interacting with senior cross-functional colleagues.

Qualifications

• 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.
• Experience in multiple therapeutic areas preferred.
• Excellent oral and written communication skills; English fluency required.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to interpret, summarize, and present statistical and medical information.
• Solid knowledge of regulatory guidance documents such as ICH requirements.

Additional Information

For US applicants: The anticipated base pay range is $117,000 to $201,250 (USD). This position is eligible for an annual performance bonus and comprehensive benefits.

[Employer hidden — sign up to reveal] is an Affirmative Action and Equal Opportunity Employer.