Manager, Regulatory Medical Writing

• Preparing and finalizing all types of clinical documents.
• Leading in a team environment.
• Working independently on assigned projects with respect to content, scientific strategy, timing, scheduling, and tracking.
• Setting objectives for others on team projects.
• Guiding or training team members on processes and best practices.
• Leading project-level writing teams.
• Providing recommendations for departmental process improvements.
• Actively participating in medical writing and cross-functional meetings.
• Coaching or mentoring junior staff and overseeing the work of others.

• 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.
• English fluency required.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to interpret, summarize, and present statistical and medical information.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Ability to build and maintain positive relationships with team members.
• Solid knowledge/application of regulatory guidance documents such as ICH requirements.
• Ability to commute to site.

Demonstrates extensive experience in medical writing and project leadership within the pharmaceutical industry, with a strong ability to prepare clinical documents and guide teams effectively. Proficient in regulatory guidance and capable of interpreting complex medical information.

• Medical Writing Experience
• Project Leadership Skills
• Regulatory Guidance Knowledge
• Statistical Information Interpretation
• Team Coaching and Mentoring

• Clinical Document Preparation
• Scientific Strategy Development
• Project Management
• Process Improvement Recommendations
• Therapeutic Area Knowledge
• Statistical Information Presentation
• Attention to Detail
• Learning Agility

• Excellent Oral Communication
• Excellent Written Communication
• Relationship Building
• Problem Solving

• University/College Degree
• Masters or PhD Preferred

• Pharmaceutical Experience
• Medical Writing
• ICH Requirements
• Submission Leadership