Pharmaceutical Regulatory Writer
3 days ago
Job Overview: We are seeking an experienced Pharmaceutical Regulatory Writer to join our team at Lifelancer. As a key member of our global organization, you will be responsible for creating high-quality clinical and safety documents for submission to regulatory authorities.
About the Role: In this role, you will work independently on complex documents, acting as an SME on clinical deliverables. You will also collaborate with Scientific communication teams, Medical regulatory writing teams, Pharmacovigilance teams, and other departments to ensure seamless execution of projects.
Key Responsibilities:
- Write and edit high-quality clinical and safety documents, including Clinical Study Reports (CSR), CTD submission documents, and Risk Management Plans (RMP).
- Work independently on documents, acting as an SME on clinical deliverables, and provide scientific inputs through peer reviews.
- Collaborate with cross-functional teams to ensure timely delivery of high-quality medical documents.
- Maintain effective relationships with stakeholders, including end-users, to develop medical regulatory content as per requirements.
- Provide deliverables within agreed timelines and quality standards.
Requirements:
- A minimum of 8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry.
- Excellent knowledge of English language skills, both written and spoken.
- Advanced degree in life sciences/pharmacy or similar discipline.
- Strong stakeholder management, communication, and project management skills.
What We Offer:
- A competitive estimated salary of $90,000-$120,000 per annum, depending on location and experience.
- A collaborative and dynamic work environment that encourages growth and development.
- The opportunity to work with a global organization, contributing to innovative solutions in the pharmaceutical industry.
How to Apply: If you are a motivated and experienced regulatory writer looking for a new challenge, please visit our website to submit your application.
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