Associate Director, Regulatory Writing - Daiichi Sankyo Inc.
Basking Ridge, NJ
About the Job
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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.
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 Qualifications (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 Qualifications
+ 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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.
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 Qualifications (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 Qualifications
+ 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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
Source : Daiichi Sankyo Inc.