Senior Regulatory Writer

6 days 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. This role offers a unique opportunity to contribute to a dynamic and rapidly growing organization.

Key Responsibilities

  • Interpret and analyze clinical trial data and study designs effectively.
  • Manage multiple projects simultaneously while fulfilling non-project responsibilities.
  • Collaborate with diverse clients and tranScrip's therapeutic and development teams.
  • Engage in non-project activities such as:
    • Identifying, interviewing, and recommending top-tier subcontractor Medical Writers.
    • Providing proactive support in managing medical writing subcontractor projects, focusing on scope, quality, timelines, and costs.
    • Assisting in the development of client proposals, ensuring quality and cost-effectiveness.
    • Leading or supporting significant business initiatives.
    • Facilitating training sessions within the company.
    • Offering assistance to project teams and colleagues as needed.
    • Mentoring and training junior team members.

Required Experience

  • Proven expertise in creating a wide range of high-quality regulatory, clinical, and scientific documents, including regulatory dossier components, protocols, clinical study reports, briefing books, and investigator brochures.
  • A minimum of 5 years of 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 various indications is a plus.
  • Demonstrated ability to prepare clinical and regulatory documents independently.
  • Successful track record in managing cross-functional teams for document development.
  • Proficient in using Endnote and conducting internet searches, including PubMed.
  • Strong project management and planning capabilities, with budget management experience.
  • 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 exceptional time management skills.
  • Strong analytical and strategic thinking abilities.
  • In-depth knowledge of local and national guidelines and regulations pertinent to medical and regulatory writing.
  • Outstanding written and verbal communication skills.
  • High level of IT proficiency, particularly with the Microsoft Office suite.
  • Excellent interpersonal skills and ability to work collaboratively within a team.
  • Willingness to travel if necessary (minimal expected).

Benefits

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

  • Permanent employment contract.
  • Competitive salary package.
  • Bonus opportunities.
  • Pension plan.
  • Life insurance coverage.
  • 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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