Creating content for a variety of deliverables for our clients including; Patient Consent and Assent forms, Patient Information Sheets, Early Access Program Protocols, RWD Protocols, Lay Summary Reports, Investigator Brochures and updates, Clinical Study Manuscripts & Clinical Study Reports
Understanding client expectations and meeting those expectations through teamwork, adherence to deadlines, scientific knowledge, and content development
Working closely with internal operational teams ensuring content is accurate and tailored to the clients’ needs
Participating in internal and external meetings to confidently discuss content and the status of deliverables
Monitoring assigned projects and managing own workload, taking ownership, and anticipating capacity issues and providing potential solution; including delegation of deliverables to medical writer vendors when required
Management of medical writer vendors, including budget and invoice management
Requirements
Prior medical writing experience in clinical research/pharmaceutical industry/medical communications
Experience working directly with clients/sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings
Bachelor’s degree in a Healthcare/Science related subject
Demonstrated understanding of early access programs, clinical research, the drug development process, and applicable regulatory guidelines and regulations
Function as a team-player, highly organised, self-motivated, and extremely detail-oriented
Strong oral and written communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite
Ability to write at a level appropriate to the target audience
Effective time management skills and ability to manage competing priorities
Ability to work in a cross-functional environment
Understanding of the integration of AI-enabled solutions to streamline documentation and reduce QC timelines
Benefits
25 days of vacation
Vacation days purchasing scheme
1 extra vacation day per each 3 years of service
Discretionary Annual Bonus
Sabbatical of 3 to 6 months (after 2 years of service)
Free food and beverages at all offices
Life Insurance
Health Insurance and Employee Assistance Programme
Employee Support Networks – help us continue to build on our inclusive culture