Scientific Writer for Regulatory Documents

3 weeks ago


Hull, Kingston upon Hull, United Kingdom Indivior PLC Full time

Synopsis:

This job offers the opportunity to work with a leading global pharmaceutical company, where you will contribute to the development of innovative solutions for patients with substance use disorders and serious mental illnesses. You will work closely with cross-functional teams to deliver high-quality regulatory submissions and ensure compliance with relevant regulations.

Duties and Responsibilities:

  • Write, review, and approve regulatory submission documents and prepare responses to questions raised by Healthcare Authorities.
  • Support the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers, including Module 2.
  • Collaborate with global regulatory, local regulatory, QA, Supply, and other relevant functions to ensure seamless delivery of Module 3.

Key Skills:

  • Bachelor's degree or higher in Chemistry or related relevant science.
  • 5-10+ years' experience of scientific writing and/or reviewing Module 3 dossiers in CTD format.
  • Proficient in basic computer applications such as Microsoft Word, Outlook, PowerPoint, Excel.

Our Benefits:

  • Competitive salary: £55,000 - £70,000 per annum.
  • 25 days holiday plus public holidays.
  • Flexible working; core hours are 10am-3pm, and we offer up to 2 days working from home/week for office-based roles.
  • Paid Volunteer Time Off.
  • 10% company pension.
  • EAP service including Legal, Health, and Wellbeing support.
  • Optional Health Insurance with BUPA.
  • Company Death in Service and Payment Protection Insurance.
  • Access to platform for discounts on gym membership, shopping, holidays.


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