Medical Writer III
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- Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
- Leading cross-functional (eg, with clinical team) document planning and review meetings.
- Interacting with cross-functional colleagues on document content and champions MW processes and best practices.
- Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
- Completing all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
- Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
- Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
- Coaching or mentoring more junior staff on document planning, processes, and content.
- Provides peer review as needed.
- Actively participating in or leads process working groups.
Requirements
- Minimum of university/college degree in a scientific discipline is required.
- An advanced degree (eg, Masters, PhD, MD) is preferred.
- At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience.
- Immunology therapeutic area experience is strongly preferred.
- Proficiency in written and spoken English is essential, along with the ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine.
- Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
Demonstrates expertise in regulatory medical writing, including the creation and coordination of clinical documents such as CSRs, protocols, and regulatory responses. Proven ability to lead cross-functional teams, mentor junior staff, and manage project timelines effectively.
Highest-signal resume keywords
- Regulatory Medical Writing
- Clinical Document Coordination
- Immunology Therapeutic Area Experience
- Project Management
- Mentoring Junior Staff
ATS Optimization Keywords
Hard Skills
- Clinical Study Reports (CSRs)
- Protocols
- Regulatory Responses
- Summary Documents
- Risk Management Plans (RMPs)
- Document Planning
- Metrics Database Management
- Project Tracking
- Time Reporting
Soft Skills
- Leadership Skills
- Collaboration
- Negotiation
- Assertiveness
- Initiative
Industry Keywords
- Pharmaceutical Industry
- Scientific Discipline
- Cross-Functional Teams
- Global Collaboration
- Time Zone Flexibility
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