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Manager, Expert Scientific Writer

3-5 years
Not Disclosed
12 Nov. 23, 2024
Job Description
Job Type: Full Time Remote Education: PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Working with Us
At Bristol Myers Squibb, every role is more than a job—it’s life-changing. Our work is uniquely challenging, meaningful, and transformative. From optimizing production lines to pioneering breakthroughs in cell therapy, we’re committed to improving the lives of patients and the careers of those who work here. Collaborate with diverse, high-performing teams and explore unparalleled opportunities for growth.

We value balance and flexibility in the workplace and offer competitive benefits, services, and programs to support personal and professional goals. Learn more at careers.bms.com/working-with-us.


概要 (High-Level Description)

This position involves leading the authoring of clinical and regulatory documents in Japan. The scope includes:

  • Clinical Study Reports (CSRs) for local Phase 2 or 3 studies.
  • Regulatory submission documents (CTD), PMDA consultation briefing documents, regulatory response documents, and orphan drug designation submissions.

You will support the performance goals for clinical development and regulatory submissions in Japan while collaborating across divisions to align with global processes and systems. The role also involves serving as the Japan Documentation Lead (JDL).


役割 (Roles & Responsibilities)

Regulatory Dossier Development

  • Build storyboards for regulatory dossier policies and align with global strategies.
  • Finalize domestic regulatory dossiers of the clinical part as the Documentation Lead.
  • Develop timelines for authoring regulatory dossiers and ensure compliance.
  • Propose optimal strategies for regulatory submissions based on PMDA review trends.
  • Complete clinical modules (J-CDL/J-CS) based on the storyboard.

Stakeholder and Operational Management

  • Manage global submission materials and coordinate with stakeholders.
  • Lead CSR authoring and manage responsibilities during inspections.
  • Oversee execution using outsourcing vendors while ensuring deliverable quality.
  • Review and edit clinical/regulatory documents as required.

Process Improvements and Mentorship

  • Identify, simplify, and implement process improvements.
  • Provide advice and mentorship to improve team capabilities in clinical/regulatory documentation.
  • Foster collaborative work environments internally and externally to strengthen Japan team communication with global counterparts and stakeholders.

必要な知識/スキル (Required Knowledge/Skills)

  • Education: PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with 3–5 years of pharmaceutical regulatory documentation experience, or equivalent.
  • Pharmaceutical Knowledge: Strong understanding of global drug development and regulatory requirements for submissions to global health authorities.
  • Writing Expertise: Demonstrated proficiency in Japanese and English scientific writing, including CTD Module 2 clinical summaries and at least one JNDA filing.
  • Analytical Skills: Ability to interpret complex data from various scientific disciplines.
  • Project Management: Proven ability to manage timelines, quality, and collaboration in cross-functional teams.
  • Technical Skills: Working knowledge of document management systems and vendor management (e.g., CROs, translation services).
  • Global Communication: Skills to read scientific documents in English and communicate effectively with global teams.

Note: If you are intrigued by this role but feel your resume does not perfectly align, we encourage you to apply. You might be one step away from work that transforms your life and career.