Daiichi Sankyo Inc.
Associate Director, Regulatory Writing
Daiichi Sankyo Inc., Basking Ridge, New Jersey, us, 07920
Daiichi Sankyo Inc. Associate Director, Regulatory Writing Basking Ridge, New Jersey Apply Now
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.Job Summary:The Associate Director of Regulatory Writing is 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.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.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.Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities and drive changes as needed.Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes.Qualifications:Education: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.We invite you to consider a career at Daiichi Sankyo, Inc.
#J-18808-Ljbffr
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.Job Summary:The Associate Director of Regulatory Writing is 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.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.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.Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities and drive changes as needed.Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes.Qualifications:Education: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.We invite you to consider a career at Daiichi Sankyo, Inc.
#J-18808-Ljbffr