Scientific Writer for Regulatory Documents
3 weeks ago
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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