Senior Clinical Writer

4 weeks ago

Wokingham, Wokingham, United Kingdom tranScrip Full time

Position Overview

We are seeking a highly skilled and proactive Senior Medical Writer to join tranScrip Ltd, a distinguished pharmaceutical consultancy known for its strategic insight, therapeutic expertise, and operational excellence throughout the product lifecycle, serving clients on a global scale.

This role offers a dynamic and diverse workload within a rapidly growing organization. The successful candidate will be responsible for project writing and must be adaptable to shifting client priorities.

Key Responsibilities

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

Required Experience

  • Extensive experience in preparing a variety of high-quality regulatory, clinical, and scientific documents, including regulatory dossier components, protocols, clinical study reports, briefing books, and investigator brochures (some medical communication tasks may also be involved).
  • A minimum of 5 years' experience as a Regulatory Medical Writer in the pharmaceutical or biotech sector, preferably within a CRO environment (10 years of experience is advantageous).
  • Experience across a broad range 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.
  • Exceptional project management and planning skills, with the ability to manage budgets effectively.
  • Experience and willingness to support business development efforts.

Qualifications

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

Personal Attributes

  • Self-driven in terms of personal growth and project engagement.
  • Adaptable and flexible in a fast-paced environment.
  • Able to perform well under pressure.
  • Proactive with excellent time management skills.
  • Strong analytical and strategic thinking abilities.
  • Thorough understanding of local and national guidelines and regulations relevant to medical and regulatory writing.
  • Outstanding 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 if necessary (minimal expected).

Benefits

This role presents a remarkable opportunity within a rapidly expanding company, offering a comprehensive benefits package that includes:

  • 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.

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