Manager, Medical Writing

• 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 providing 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.

• 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.

Demonstrates extensive experience in medical writing, project leadership, and regulatory compliance, with a strong ability to mentor junior staff and guide cross-functional teams. Proficient in preparing clinical documents while ensuring adherence to industry standards and best practices.

• Medical Writing Experience
• Project Leadership
• Regulatory Guidance Knowledge
• Cross-Functional Team Collaboration
• Attention to Detail

• Clinical Document Preparation
• Scientific Strategy Development
• Statistical Information Presentation
• Process Improvement Recommendations
• Project/Time Management

• Excellent Oral Communication
• Excellent Written Communication
• Problem-Shooting
• Mentoring
• Relationship Building

• Pharmaceutical Experience
• Submission Leadership
• Therapeutic Areas
• ICH Requirements
• Medical Writing Standards