Associate Director, Regulatory Writing

Daiichi Sankyo; Basking Ridge (NJ); Sur place; USD 158 000 - 237 000; Plein temps

Résumé du poste

Daiichi Sankyo, a global healthcare leader, seeks an Associate Director, Regulatory Writing to produce high-quality regulatory documents and meet strict timelines. This role collaborates across functions and focuses on BLA/MAA submissions, CSRs, and briefing books while managing information flow and strategy.

The candidate will contribute scientific insights, oversee complex documents, and guide study teams on regulatory expectations, ICH guidelines, and filing readiness within a dynamic

Qualifications

• 4+ years of medical writing with graduate degree (Doctorate preferred) in relevant science field
• 7+ years of medical writing with a Bachelor's degree in relevant science field
• Submission document writing experience required

Responsabilités

• 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 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 at the study team level including recommendations for data outputs and support authoring documents for filings or responses to health authority requests
• Advise study teams on regulatory requirements and ICH guidance for clinical documents
• Participate in Global Regulatory Writing Group initiatives to identify improvements and drive changes
• Assess resource needs, identify issues and propose solutions, help develop timelines and processes

Connaissances

Medical writing

Regulatory writing

Clinical documentation

IND/NDA/MAA submissions

Regulatory strategy

Formation

Bachelor's degree

Master's/PhD preferred

Description du poste

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

The Associate Director, 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, 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

Job Description

• 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

Education Qualifications

• Bachelor's Degree required
• Master's Degree or PhD in relevant science field preferred

Experience Qualifications

• 4+ years of experience as a medical writer with a graduate degree (Doctorate preferred) in a relevant science field or 7+ years of experience as a medical writer with a Bachelor's degree in a relevant science field required
• Submission document writing experience required

Travel Requirements

Ability to travel up to 5% of the time. 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.

Salary Range

USD$157,920.00 - USD$236,880.00