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Principal Medical Writer

3 months ago

Wokingham, Wokingham, United Kingdom tranScrip Full time

Position Overview

An exceptional opportunity has emerged for a seasoned and proactive Senior Medical Writer to join tranScrip Ltd, a specialized pharmaceutical consultancy renowned for its strategic insight, therapeutic expertise, and operational excellence throughout the product lifecycle, catering to clients on a global scale.

This role is dynamic and encompasses a diverse range of responsibilities within a rapidly growing organization. The position involves project writing and requires an adaptable individual who can respond to client needs effectively.

Key Responsibilities

  • Interpret and analyze study designs and clinical trial data.
  • Manage multiple projects simultaneously while handling additional responsibilities.
  • Collaborate with a diverse array of clients and tranScrip's therapeutic and development teams.
  • Engage in non-project tasks such as:
  • Identifying, interviewing, and recommending top-tier subcontractor Medical Writers.
  • Providing proactive support in managing medical writing subcontractor projects concerning scope, quality, timelines, and costs.
  • Assisting in the scoping, costing, and quality assurance of client proposals.
  • Leading or supporting significant business initiatives.
  • Facilitating or contributing to training within the organization.
  • Providing assistance to project teams and colleagues as needed.
  • Mentoring and training junior team members.

Required Experience

  • Proven experience in producing a wide variety of high-quality regulatory, clinical, and scientific documents, including regulatory dossier components, protocols, clinical study reports, briefing documents, and investigator brochures (some medical communication tasks may also be required).
  • A minimum of 5 years' experience as a Regulatory Medical Writer in the pharmaceutical or biotech sector, preferably within a CRO setting (10 years of experience is advantageous).
  • Experience across a broad spectrum of indications is beneficial.
  • Demonstrated ability to prepare clinical and regulatory documents independently.
  • Proven experience in cross-functional team management for document development.
  • Proficient in using Endnote and conducting internet searches, including PubMed.
  • Excellent project management and planning capabilities, with the ability to manage budgets effectively.
  • Experience and willingness to support business development efforts.

Qualifications

  • A degree in life sciences, preferably at a higher level (e.g., MSc, PhD).

Personal Attributes

  • Self-driven in terms of personal growth and project engagement.
  • Flexible and adaptable in a fast-paced environment.
  • Able to perform well under pressure.
  • Proactive with outstanding time management skills.
  • Strong analytical and strategic thinking abilities.
  • Comprehensive knowledge of local and national guidelines and regulations pertinent to medical and regulatory writing.
  • Exceptional written and verbal communication skills.
  • High level of IT proficiency, particularly with the Microsoft Office suite.
  • Strong interpersonal skills and ability to work collaboratively in a team.
  • Willingness to travel as necessary (minimal expected).

Benefits

This role offers a fantastic opportunity within a rapidly expanding company, providing excellent benefits, including:

  • Permanent employment contract.
  • Competitive salary.
  • Bonus program.
  • Pension plan.
  • Life insurance.
  • Group income protection.
  • Private health and travel insurance.
  • Retail discounts.
  • Strong emphasis on continuous professional development.

Work Environment

  • The Senior Medical Writer position is primarily office-based, with the possibility of some remote work for the right candidate.