Senior Medical Content Specialist

6 days ago

London, Greater London, United Kingdom Lifelancer Full time

About the Role

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As a Senior Medical Content Specialist at Lifelancer, you will be responsible for guiding medical writing document preparation, including coordinating assignments to writers, reviewing, and substantively editing documents. You may assume primary responsibility for preparing key regulatory response documents and documents supporting major regulatory submissions. Your expertise will involve formulating a writing approach, developing timelines, and assessing resource requirements for key documents and regulatory submissions within designated therapeutic or functional areas.

You will participate in relevant project teams and task forces, providing functional and cross-functional guidance on various issues related to document preparation, including international regulatory guidance and requirements for content and format, work requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.

Key Responsibilities

  • Develop and lead the writing strategy, providing expertise on organization, content, timelines, and resource requirements.
  • Provide complex advanced input for study designs, analysis plans, sections of INDs, and marketing applications.
  • Review and substantively edit contributions, ensuring issue resolution.
  • Manage deliverables and prepare documents for submission to regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Sponsor requirements and processes across development programs.
  • Represent Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
  • Act as a key Medical Point of contact for clinical regulatory strategy.
  • As required, serve as lead writer for important regulatory response documents and key components of regulatory submissions.
  • Provide leadership on functional teams addressing requirements or issues related to document preparation and production.
  • The Senior Medical Content Specialist is seen as an expert in medical writing and performs work independently with minimal supervision.

Requirements and Qualifications

  • Bachelor's degree in science, health profession required.
  • At least 7 years of experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
  • Experience as lead writer for key documents included in major international regulatory submissions required, like Clinical study reports, IBs, Protocols.
  • Experience managing writing activities for a major international regulatory submission preferred.

About ICON

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. We are dedicated to providing an inclusive and accessible environment for all candidates.

We offer a competitive salary range of £45,000 - £65,000 per annum, depending on your level of experience and qualifications. Our benefits package includes various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, a Global Employee Assistance Programme, life assurance, and flexible country-specific optional benefits.

About This Opportunity

This is an exciting opportunity to join our team as a Senior Medical Content Specialist. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply. Please visit our careers website to learn more about this role and how to apply.

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