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Medical Writer
2 months ago
Chiesi USA is a specialty pharmaceutical company dedicated to developing and promoting products for the hospital, adjacent specialty, and rare disease markets. We are a B Corp and Benefit company, recognized for our commitment to social and environmental responsibility.
Job SummaryWe are seeking a highly skilled Medical Writer to join our team. As a Medical Writer, you will be responsible for crafting and reviewing content for a wide range of scientific and regulatory documents. Your expertise will be essential in generating high-quality, coherent, and scientifically robust documentation.
Main Responsibilities- Write, edit, and/or format clinical study protocols, clinical study reports, investigator's brochures, eCTD written/tabular summaries, and clinical overviews.
- Independently perform scientific/medical writer tasks, coordinating document preparation, review, and approval.
- Leverage extensive hands-on prior experience interacting with regulatory authorities to ensure timely and successful responses to authority questions and/or requests.
- Provide expertise and leadership for the development and implementation of role-relevant tools, SOPs, and templates.
- Coordinate and manage teams of external medical writers and internal subject matter experts involved in the preparation of dossiers for marketing approval and life cycle management of approved products.
- Experience in writing clinical study protocols, clinical study 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 the structure, format, and content of regulatory documents (e.g., ICH E3, E6, E9).
- Advanced knowledge of the drug development process, relevant regulations, and the needs of relevant stakeholders.
Chiesi USA is an equal opportunity employer committed to hiring a diverse workforce. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance.
