Regulatory Medical Writer Lead

Há 10 horas


Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro
Job Description:

A challenging opportunity has arisen for a highly skilled Regulatory Medical Writer Lead to join Prime Vigilance Ltd, a leading global company specializing in pharmacovigilance services.

Job Summary:

The successful candidate will be responsible for leading a team of medical writers in the preparation of high-quality regulatory documents, including aggregate reports, risk management plans, and other critical documents.

Key Responsibilities:
  • Lead a team of medical writers in the preparation of regulatory documents, ensuring timely delivery and adherence to quality standards.
  • Develop and implement strategies to improve document quality, efficiency, and productivity.
  • Collaborate with cross-functional teams, including pharmacovigilance operations and quality assurance, to ensure alignment and effective communication.
  • Mentor and train junior medical writers to enhance their skills and knowledge.
  • Stay up-to-date with industry developments, regulatory requirements, and best practices to maintain expertise and provide guidance to the team.
Requirements:
  • Proven experience as a medical writer or lead, with a strong background in pharmacovigilance and regulatory affairs.
  • Pharmacist or MD degree, with advanced knowledge of English language.
  • Excellent leadership, communication, and project management skills, with ability to prioritize tasks and manage multiple projects simultaneously.
  • Ability to work independently and collaboratively in a fast-paced environment.
Salary and Benefits:

We offer an attractive salary package, estimated at $120,000 - $180,000 per annum, depending on experience and qualifications. Additionally, we provide comprehensive benefits, including health insurance, retirement plan, and opportunities for career growth and professional development.

About Us:

At Prime Vigilance Ltd, we value diversity, equity, and inclusion, creating a workplace where everyone can thrive and contribute to our mission. We offer training and career development opportunities, a supportive work environment, and the chance to collaborate with colleagues worldwide.


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