Medical Writer
1 day ago
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty, and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
Key Responsibilities:- Write, edit, and/or format a wide range of documents required for clinical development and post-approval life cycle management, including clinical study protocols, clinical study reports, investigator's brochures, eCTD written/tabular summary, 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 a timely and successful response 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.
- Proficient in interpretation of complex data and excellent knowledge of statistics, study design, and data reporting.
- 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 level written and spoken English.
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Medical Writer
1 week ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
1 week ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
4 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
6 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
6 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
5 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
4 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
3 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
7 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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Medical Writer
7 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi USAChiesi 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...
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