Senior Medical Writer
1 week ago
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 writing 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.
-
Senior Medical Writer
17 hours ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeSenior Medical Writer Opportunity at Thermo Fisher ScientificWe are seeking a highly skilled Senior Medical Writer to join our team at Thermo Fisher Scientific. As a Senior Medical Writer, you will play a critical role in creating high-quality medical and scientific content for our clients.Key Responsibilities:Develop and maintain a deep understanding of our...
-
Senior Medical Writer
20 hours ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeSenior Medical Writer Opportunity at Thermo Fisher ScientificWe are seeking a highly skilled Senior Medical Writer to join our team at Thermo Fisher Scientific. As a Senior Medical Writer, you will play a critical role in creating high-quality medical and scientific content for our clients.Key Responsibilities:Develop and maintain a deep understanding of our...
-
Senior Medical Writer
4 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi GroupChiesi 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 SummaryWe are seeking a...
-
Senior Medical Writer
4 days ago
Toronto, Ontario, Canada Chiesi Group Full timeAbout Chiesi GroupChiesi 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 SummaryWe are seeking a...
-
FSP Senior Medical Writer
3 weeks ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeWork ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSenior Medical Writer (North America) (FSP; Remote)At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and...
-
Medical Writer and Content Lead
1 week ago
Toronto, Ontario, Canada McCann Health Canada | An IPG Health Company Full timeAbout the Role:As a Senior Medical Writer and Content Lead at McCann Health Canada | An IPG Health Company, you will play a critical role in developing and implementing high-quality medical content that drives business results. This is a unique opportunity to leverage your expertise in medical writing and content strategy to make a meaningful impact on the...
-
Medical Writer and Content Lead
1 week ago
Toronto, Ontario, Canada McCann Health Canada | An IPG Health Company Full timeAbout the Role:As a Senior Medical Writer and Content Lead at McCann Health Canada | An IPG Health Company, you will play a critical role in developing and implementing high-quality medical content that drives business results. This is a unique opportunity to leverage your expertise in medical writing and content strategy to make a meaningful impact on the...
-
Principal Medical Writer
9 hours ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeSenior Medical Writer (Canada) Job Description A senior medical writer is needed to provide high-quality medical and scientific writing for a client in the Immunology therapeutic space. Job Responsibilities: Write and provide input on routine documents such as clinical study reports and study protocols. Research, write or edit complex clinical and...
-
Principal Medical Writer
2 weeks ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionSenior Medical Writer (Canada) (FSP; Client Embedded Remote)At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer....
-
Senior Medical Writer
1 week ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Writer to join our FSP team at Thermo Fisher Scientific. As an embedded writer, you will work closely with a client in the Immunology therapeutic space, providing high-quality medical and scientific writing services.Key ResponsibilitiesDevelop and deliver high-quality medical and scientific writing...
-
Senior Medical Writer
1 week ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Writer to join our FSP team at Thermo Fisher Scientific. As an embedded writer, you will work closely with a client in the Immunology therapeutic space, providing high-quality medical and scientific writing services.Key ResponsibilitiesDevelop and deliver high-quality medical and scientific writing...
-
Senior Medical Writer
4 days ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Writer to join our FSP team at Thermo Fisher Scientific. As an embedded writer, you will work closely with a client in the Immunology therapeutic space, providing high-quality medical and scientific writing services.Key ResponsibilitiesDevelop and deliver high-quality medical and scientific writing...
-
Senior Medical Writer
4 days ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Writer to join our FSP team at Thermo Fisher Scientific. As an embedded writer, you will work closely with a client in the Immunology therapeutic space, providing high-quality medical and scientific writing services.Key ResponsibilitiesDevelop and deliver high-quality medical and scientific writing...
-
Senior Medical Writer
2 weeks ago
Toronto, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Writer to join our team at Thermo Fisher Scientific. As a Senior Medical Writer, you will be responsible for providing high-quality medical and scientific writing services to our clients in the Immunology therapeutic space.Key ResponsibilitiesDevelop and maintain a deep understanding of the...
-
Senior Medical Content Specialist
5 days ago
Toronto, Ontario, Canada McCann Health Canada | An IPG Health Company Full timeAbout McCann Health Canada | An IPG Health CompanyWe are a leading healthcare agency that helps brands play a meaningful role in people's lives. Our team of experts is dedicated to delivering innovative and effective solutions that drive business results.Job Title: Senior Medical WriterWe are seeking a highly skilled Senior Medical Writer to join our team....
-
Senior Medical Content Specialist
5 days ago
Toronto, Ontario, Canada McCann Health Canada | An IPG Health Company Full timeAbout McCann Health Canada | An IPG Health CompanyWe are a leading healthcare agency that helps brands play a meaningful role in people's lives. Our team of experts is dedicated to delivering innovative and effective solutions that drive business results.Job Title: Senior Medical WriterWe are seeking a highly skilled Senior Medical Writer to join our team....
-
Lead Medical Writer
4 weeks ago
Toronto, Ontario, Canada ThermoFisher Scientific Full timeThermo Fisher Scientific Lead Medical Writer - FSP (North America) Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Overview Senior Medical Writer (FSP; Remote) At Thermo Fisher Scientific, we are committed to impactful work that contributes positively on a global scale. Join our team in fulfilling our Mission - empowering our...
-
Medical Writer Specialist
20 hours ago
Toronto, Ontario, Canada Chiesi Group Full time{"h2": "About the Role", "p": "At Chiesi USA, we are seeking a highly skilled Medical Writer to join our team. As a Medical Writer, you will be 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. Your expertise will be essential in...
-
Medical Writer Specialist
17 hours ago
Toronto, Ontario, Canada Chiesi Group Full time{"h2": "About the Role", "p": "At Chiesi USA, we are seeking a highly skilled Medical Writer to join our team. As a Medical Writer, you will be 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. Your expertise will be essential in...
-
Senior Medical Content Strategist
4 days ago
Toronto, Ontario, Canada Publicis Health Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Writer to join our team at Publicis Health Toronto. As a Senior Medical Writer, you will be responsible for adapting, creating, and editing copy for multiple Canada pharma therapeutic areas for both medical communication and commercial purposes.Key ResponsibilitiesDevelop and implement effective...