Medical Writer H/F

Summary / purpose of the position

To generate consistently high-quality clinical documentation content, working across multiple accounts and projects seamlessly. The incumbent is a contributing scientific expert in their allocated therapy areas and can accurately incorporate strategic concepts into projects. In addition to this, the incumbent is responsible for preparing regulatory documents for submission to regulatory authorities within subject area (clinical/safety). Working with minimal guidance, the incumbent will take accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions.

Main responsibilities / job expectations

Main Medical Writing responsibilities

• Manages the preparation of a complex suite of regulatory documents e.g. investigator brochures, protocols, CSRs, briefing documents, meeting requests, CTD Clinical modules.
• Writes/Edits complex clinical documents
• Reviews documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier
• Plans and creates timelines to produce assigned documents.
• Actively contributes to best practices and continuous improvement within the R&D.
• Represents the group in functional and cross functional initiatives/projects when required
• Networks and shares best practices to ensure efficiency and consistency across product teams
• For company acquisitions or licensed assets, as requested, provides subject matter expertise in effective integration planning, implementation and monitoring of integration activities within the CDO integration team in collaboration with CDO integration Lead.

Project Delivery    

• Able to work across multiple projects simultaneously
• Demonstrates a thorough understanding of timelines, budgetary constraints and scopes of work
• Adheres to the quality control process and ensure all work produced has gone through the correct internal review process
• Demonstrates a good understanding of project management and resource planning
• Maintains a working knowledge of pharmaceutical industry standards and compliance

Communication

• Understands the purpose and role of communications in the wider therapy area and commercial landscape
• Demonstrates the ability to communicate clearly to different audiences through a variety of media (print and digital)
• Identifies and communicates important therapy area updates and any medical/regulatory milestones to the team and clients where appropriate. Link this with any potential new business opportunities where applicable
• Provides regular feedback to senior teams across accounts and projects

EHS responsibilities

• Complies with applicable EHS regulations and procedures.
• Participates in the site's EHS performance by reporting risks, malfunctions or improvements
• Participates in mandatory EHS training

Knowledge, abilities & experience

Education / Certifications:

• Life sciences degree, preferably MSc or PhD or equivalent combination of education and experience

Experience:

• Minimum 2 years Medical Writing experience in either a CRO or pharmaceutical company
• Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired
• Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology would be advantageous
• Recognised industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations) would be advantageous
• Proficient in using Microsoft Office (e.g. PowerPoint, Excel)
• Have an excellent command of the English language in both written and verbal communications desirable
• Previous experience in industry would be advantageous
• A keen interest in working and developing scientific expertise across a range of therapy areas
• Flexible approach to working, with the ability to reprioritise and work under pressure when needed
• Excellent time management skills and demonstrated ability to forecast and manage workload

Languages:

• English (Excellent level both written and verbal)

Key Technical Competencies Required

• Experience as a clinical/regulatory/safety Medical Writer, e.g. preparation of a wide range of clinical/regulatory documents including clinical study reports, protocols, participant narratives, investigator brochures, regulatory submission modules, safety reports, and manuscripts.
• Able to manage coordination responsibilities beyond writing individual documents, e.g. timelines, reviews and submissions

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