Job Title: Clinical Regulatory Medical Writer
Location: Remote (EU Based-UK or Denmark preferred)
Overview
- Medical Writer to work as an embedded team member in a mid- to large pharmaceutical company working on 3 major submissions along with ongoing program support activities.
- Full-time equivalent utilization
- Will use own equipment within the sponsor’s e-workspace
- EU required; UK or Denmark preferred
- For Denmark professionals, will go onsite 2-4 times per month and/or for major team meetings/comment resolution meetings
- Process to engagement: Resume and completed MW document grid to be submitted to client for review; start date is 1-2 months
Document Experience
- Protocols
- Investigator's Brochures
- CSRs/CTRs
- Submission document experience such as M2.5 Clinical Overview (Addendums), M2.7 Clinical summaries (focusing on 2.7.3 and 2.7.4)
- Briefing books and other ad hoc documents
Soft skills
- Strong ability to drive teams and documents to success
- Strong ability to demonstrate enthusiasm and team awareness
- Adaptable to move to different documents as needed
- Proactive and interactive—reach out to team members as needed to ensure document success
- Resourceful and able to move the document forward despite team’s challenges
- Ability to work quickly
- Fluency in English