[Hiring] (Senior) Medical Writer @Bionical Emas

Role Description

We are looking for a (Senior) Medical Writer who will be responsible for leading and managing the medical writing activities across the company, including researching, creating, and editing all documents associated with all Early Access Programmes, including Real-World Data (RWD). They will operate as the primary client contact for content development and facilitate process improvement to ensure all deliverables are of the highest quality, accurate, and meet the clients’ needs.

• 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 solutions; including delegation of deliverables to medical writer vendors when required
• Management of medical writer vendors, including budget and invoice management

Qualifications

• 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
• Flexible and hybrid work