Senior Medical Writer
Bionical Emas
full-time
Posted on:
Location Type: Remote
Location: United Kingdom
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Job Level
About the role
- 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
- Flexible and hybrid work
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingclinical researchdocument preparationcontent developmentbudget managementinvoice managementregulatory guidelinesdrug development processearly access programsquality control
Soft Skills
teamworkself-motivateddetail-orientedoral communicationwritten communicationinterpersonal skillstime managementorganizational skillscross-functional collaborationproblem-solving