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Lead Medical Writer

3 months ago

Wokingham, Wokingham, United Kingdom tranScrip Full time

Position Overview

We are seeking a highly skilled and motivated Senior Medical Writer to join tranScrip Ltd, a distinguished pharmaceutical consultancy renowned for its strategic insights and operational excellence throughout the product lifecycle. This role is ideal for an individual with robust project management capabilities and a proactive approach to medical writing.

Key Responsibilities

  • Interpret and analyze clinical trial data and study designs effectively.
  • Manage multiple projects simultaneously while balancing additional responsibilities.
  • Collaborate with diverse clients and tranScrip's therapeutic and development teams.
  • Engage in non-project tasks such as:
    • Identifying and recommending qualified subcontractor Medical Writers.
    • Overseeing medical writing subcontractor projects with a focus on scope, quality, timelines, and costs.
    • Assisting in the development and quality assurance of client proposals.
    • Leading or contributing to key business initiatives.
    • Facilitating training sessions within the organization.
    • Providing support to project teams as needed.
    • Mentoring junior team members.

Required Experience

  • Proven experience in creating a variety of high-quality regulatory, clinical, and scientific documents, including regulatory submissions, protocols, clinical study reports, and investigator brochures.
  • A minimum of 5 years in a Regulatory Medical Writing role within the pharmaceutical or biotech sectors, preferably in a CRO setting.
  • Experience across a broad spectrum of therapeutic areas is a plus.
  • Demonstrated ability to prepare clinical and regulatory documents independently.
  • Strong track record in managing cross-functional teams for document development.
  • Proficient in using Endnote and conducting internet research, including PubMed.
  • Exceptional project management and planning skills, with budget management experience.
  • Willingness to support business development initiatives.

Educational Qualifications

  • A degree in life sciences, with a preference for advanced degrees (e.g., MSc, PhD).

Personal Attributes

  • Self-driven with a commitment to personal and professional growth.
  • Adaptable and flexible in a fast-paced environment.
  • Ability to perform well under pressure.
  • Proactive with excellent time management skills.
  • Strong analytical and strategic thinking abilities.
  • In-depth knowledge of relevant local and national medical writing regulations and guidelines.
  • Outstanding written and verbal communication skills.
  • High level of proficiency in IT, particularly with Microsoft Office applications.
  • Strong interpersonal skills and ability to work collaboratively in a team.
  • Willingness to travel as necessary (minimal expected).

What We Offer

This is an exceptional opportunity within a rapidly growing organization, providing a comprehensive benefits package that includes:

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

Work Environment

  • This position is primarily office-based, with the possibility of remote work for the right candidate.