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About Chiesi Group
Chiesi Group is a leading pharmaceutical company dedicated to developing and promoting innovative products for the hospital, specialty, and rare disease markets. As a B Corp and Benefit company, we prioritize social and environmental responsibility, ensuring the well-being of our people, patients, and communities.
Job Summary
We are seeking a highly skilled Senior Medical Writer to join our team. As a key member of our Clinical Development department, you will be responsible for crafting and reviewing high-quality scientific and regulatory documents, collaborating closely with cross-functional teams to ensure timely and successful submissions.
Main Responsibilities
- Write, edit, and format a wide range of documents, including clinical study protocols, reports, investigator brochures, and regulatory submissions.
- Independently perform scientific/medical writer tasks, coordinating document preparation, review, and approval.
- Leverage extensive experience interacting with regulatory authorities to ensure timely and successful responses to questions and requests.
- Provide expertise and leadership in developing and implementing role-relevant tools, SOPs, and templates.
- Coordinate and manage teams of external medical writers and internal subject matter experts involved in dossier preparation and life cycle management.
- Support, train, and guide subject matter experts on good writing practices and document formatting requirements.
- Work closely with Clinical Programs, Statistics, and Regulatory functions to ensure objectives are met in a timely fashion and of high quality.
- Maintain high standards and levels of scientific and clinical knowledge in relevant therapeutic and disease areas.
- May contribute to scientific publications, abstracts, and presentations at conferences.
Requirements
- Experience in writing clinical study protocols, reports, regulatory briefing documents, and clinical trial dossiers.
- Familiarity with regulatory requirements and guidelines in drug development (e.g., FDA, EMA).
- Advanced knowledge of relevant regulations/guidance on document structure, format, and content (e.g., ICH E3, E6, E9).
- Advanced knowledge of the drug development process, relevant regulations, and stakeholder needs.
- Proficient in interpreting complex data and excellent knowledge of statistics, study design, and data reporting.
Education
- Relevant life science university degree, PhD, or Pharm. D in Biochemistry, Pharmacology, or a related field.
- Background knowledge in rare diseases is highly desirable.
- Fluent written and spoken English.
