Associate Director, Regulatory Writing
1 week ago
Join a Legacy of Innovation 110 Years and Counting
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:
The Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, NDAs, BLAs, MAAs. This role will also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).
Responsibilities:
Write critical, complex clinical and clinical pharmacology documents (eg, pivotal Phase 3 CSRs, NDA/BLA/MAA submission documents, and briefing books) with minimal input from functional area experts; Ensure key messages are clear and consistent within and across documents.
Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency.
Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data and support the authoring of documents for filings or responding to health authority requests; Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents.
Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, potential collaborations and drive changes as needed.
Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education: (from an accredited college or university)
Bachelor's Degree required.
PhD in relevant science field preferred.
Master's Degree in relevant science field preferred.
Experience:
4 or More Years of experience as a medical writer with a graduate degree (Doctorate preferred) in a relevant science field.
7 or More Years of experience as a medical writer with a bachelor's degree in a relevant science field.
Submission document writing experience required.
Travel:
Ability to travel up to 5% In-house/remote office position that may require domestic/global travel.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
-
Associate Director, Regulatory Operations
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...
-
Associate Director Regulatory Affairs
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...
-
Associate Director, Regulatory Operations
3 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Associate Director, Clinical Pharmacology
2 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingCompany is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration....
-
Associate Director, Clinical Pharmacology
3 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration....
-
Director, Global Regulatory Affairs
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...
-
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Associate Director, US Regulatory Affairs Strategy
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...
-
Associate Director, US Regulatory Affairs Strategy
3 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Director, Global Regulatory Affairs
3 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Basking Ridge, New Jersey, United States Planet Pharma Full timeJob Summary:Planet Pharma is seeking an experienced Associate Director, Clinical Safety MD to join our team. As a key member of our Safety Management Team, you will be responsible for supporting safety monitoring and risk management activities for products in development.Key Responsibilities:Signal Identification and Evaluation: Conduct routine signal...
-
Director, US Regulatory Affairs Strategy
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...
-
Director, US Regulatory Affairs Strategy
3 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Senior Scientist/Associate Director RACMC
3 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Associate Director, Clinical Safety MD
3 weeks ago
Basking Ridge, United States Planet Pharma Full time-- Duties: Job Title: Associate Director, Clinical Safety MD Job Schedule: Candidate can work 100% remote for duration of assignment. EST/CST time zone-based candidates preferred. Position supports safety monitoring and risk management activities for products in development. This position will work closely with a senior physician. Additionally,...
-
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...
-
Associate Director, Global Clinical Operations
3 weeks ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a...
