Principal Medical Writer
4 months ago
Chiesi USA
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.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. 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, meeting exciting challenges, and engaging in important and rewarding work.
- Responsible for crafting and reviewing content of a wide range of scientific and/or regulatory documents required for clinical development and post-approval life cycle management, generating high quality, coherent and scientifically robust documentation in close collaboration with the appropriate matrixed team members
- Independently work on clinical study reports, protocols and amendments, investigator brochures, briefing documents and regulatory submission documentation
- Support the co-ordination and oversight of medical writing activities across GRD Clinical Development programs
- Write, edit, and/or format a wide range of documents of 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, briefing book, response documents
- 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
- Leverage extensive hands-on prior experience interacting with regulatory authorities to ensure the optimal presentation of complex information, and that it is articulate, coherent, scientifically robust and convincing
- 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
- Support, train, and guide relevant interacting subject matter experts on good writing practices and the structure/formatting requirements for scientific/regulatory documents
- Work closely with Clinical Programs, Statistics and Regulatory functions ensuring objectives in a study and program are met in a timely fashion and are of high quality
- Maintain high standards and levels of scientific and clinical knowledge in the relevant therapeutic and disease area(s)
- May contribute to scientific publications, abstracts, and presentations at conferences
- Experience in writing clinical study protocols, clinical study reports, regulatory briefing documents, 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), on relevant technical specifications (e.g., ICH M4)
- 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
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
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