Summary / Purpose Of The Position

To generate consistently high-quality documentation content, working across multiple accounts and projects seamlessly. The incumbent is a contributing scientific expert across therapy areas and can accurately incorporate strategic concepts into projects whilst guiding others. In addition to this, the incumbent is responsible for preparing regulatory documents for submission to regulatory authorities within subject area (non clinical focus). 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. Applying project management expertise and contributing to functional excellence through process management, the incumbent will also play a role in guiding other medical writers.

Main Medical Writing Responsibilities

• Manages the preparation of documents focusing on non clinical data e.g. early development stage investigator brochures, briefing documents, meeting requests, IND/CTA/CTD non clinical modules.
• Leads writing/editing complex documents
• Reviews documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a regulatory dossier
• Plans and creates timelines to produce assigned documents.
• Actively contributes to best practices and continuous improvement within the RD.
• Represents the group in functional and cross functional initiatives/projects when required.
• Networks and shares best practices to ensure efficiency and consistency across RD.
• 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 and accounts 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 RD landscape
• Demonstrates the ability to communicate clearly to different audiences through a variety of media (print and digital)
• Identifies and communicates important field area updates and any regulatory milestones to the functional and project team 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 sites 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, pharmacology, pharmacokinetics, and regulatory environment would be advantageous
• Proficient in using Microsoft Office (Word, PowerPoint, Excel)
• 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

• Have an excellent command of the English language in both written and verbal communications is desirable
  
  

Key Technical Competencies Required

• Experience as a non clinical/regulatory/ Medical Writer, e.g. preparation of a wide range of non clinical/regulatory documents including IND/CTD modules, early stage investigator brochures, and manuscripts.
• Able to manage coordination responsibilities beyond writing individual documents, e.g. timelines, reviews and submissions