Medical Writer
Celerion
Swift
Job Level
Lead
About the role
- Serve as the project physician providing medical and scientific expertise to project teams
- Ensure accuracy and integrity of trial data with a concentrated focus on patient safety
- Participate in strategic planning and execution of development programs in Hematology and Oncology
- Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement
- Support Business Development and Proposals teams: participate in RFP process, prepare medical considerations, and support bid defense
- Write or edit scientific content of deliverables within budget and timelines
- Collaborate with Regulatory Affairs on regulatory product landscape and development strategies
- Provide scientific insight and create content for company releases, white papers, and publication manuscripts
- Review and revise protocols, case report forms, training materials, project tools, analysis plans, clinical trial reports, and new drug applications
- Review laboratory values, adverse events, coded adverse event and medication data, and data tables/listings/figures as needed
- Serve as a medical resource for study sites, project teams, and clients
- Assist in preparation of Medical Monitoring Plan and materials for investigator meetings and staff training
- Assume responsibility for medical and safety monitoring on assigned projects
- Participate in feasibility discussions related to specific project proposals
- Develop training modules and provide disease-state training
- Participate in process improvement activities
- Collaborate with VP, Global Medical and Medical Science Department to support global growth and development activities
Requirements
- MD, DO, MBBS, or equivalent medical qualifications
- 5+ years of Hematology clinical experience
- Ability to strategically analyze Hematology and oncology clinical trial protocols
- Availability for domestic and international travel including overnight stays (approximate 30% travel requirement)
- Hematology Fellowship or equivalent (preferred)
- Maintains current scientific and medical knowledge base (preferred)
- Ability to deliver on commitments and understand service culture
- Strategic thinker able to build drug development solutions, novel study designs, and patient population strategies
- Demonstrates professionalism, punctuality, and strong interpersonal skills
- Strong verbal and written communication skills
- Experience conducting formal presentations to diverse audiences
- Strong visual and presentation skills
- Ability to work effectively in a fast-paced team setting with minimal supervision
- Proven efficiency in working remotely
