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Position Summary
Lead the authoring of clinical/regulatory documents in Japan.
The scope of clinical/regulatory documents includes clinical study reports (CSR) for local Ph 2 or 3 study, regulatory submission documents (CTD), briefing document for PMDA consultation, regulatory response documents, orphan drug designation.
- Lead the authoring of clinical/regulatory documents and support the performance goals (including quality and timeline) for the clinical development and regulatory submission in Japan as planned by the R&D Development Teams.
- Establish cross-divisional cooperative partnership with other functions according to the optimized and standardized processes and systems.
- Fulfill the role of Japan Documentation Lead.
Duties/Responsibilities
Play the following roles and take responsibilities at each phase in the life cycle of the BMSKK asset;
- Build the storyboard to author regulatory dossier policies and align with global team based on the information provided by DT.
- As DOC lead, understand the global authoring regulatory dossier strategy and lead the finalizing of domestic regulatory dossiers of clinical part.
- Set an appropriate and the shortest timeline to complete authoring regulatory dossiers and comply with the timeline.
- Propose to the team the optimal strategy for preparing regulatory submission documents based on the tendencies of each review division concerning the contents of PMDA review reports and inquiries.
- Complete the clinical modules with J-CDL/J-CS based on the storyboard.
- Manages and provides global submission materials to stakeholders as needed.
- Authoring and conducting a coordinating activity as CSR author.
- Take charge of the CSR authoring part in the inspection.
- Manage the operational execution by strategically using outsource vendors and ensure quality of deliverables.
- Comply with internal and external processes and guidelines.
- Review and edit other clinical/regulatory documents as required.
- Drive continuous process improvements by identifying and simplifying processes. Lead implementation of business process improvements based on information from collected metrics.
- Give advice to other scientific writers to help them improve their capabilities in creation of clinical/regulatory documents for Japan.
- Provide additional value by creating better collaborative work environment internally and externally to ensure that Japan team has a good communication with HQ counterparts as well as key stakeholders, such as clinical research and regulatory.
Qualifications
B.S. in medical / pharmaceutical / veterinarian / life-science area or three years or more experience in either pharmaceutical R&D industry is mandatory.
- PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a minimum of 3 years (MS) to 5 years (BS) in preparing regulatory submission documents or have equivalent credentials and experience.
- Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
- Good understanding of the tendency of each review department of PMDA regarding the contents of review reports and inquiries.
- Demonstrated ability required for strong writing skills both in Japanese and in English, preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA. Samples of required and experienced abilities are the followings:
- Capable of updating appropriately the first draft of M2.5.1 and M2.5.6 authored by J-CDL/J-CS and providing appropriate advice when authoring the first draft, or can prepare the first draft in collaboration with J-CDL/J-CS
- Capable of independently finalizing other clinical modules getting cooperation from R&D Development team.
- Also, capable of independently authoring the draft inquiry to regulatory regarding clinical matters.
- Experience in authoring the clinical part of the pre-JNDA/Eop2 consultation documents.
- Capable of communicating with the Global team about the contents/strategies of the authoring documents such as CTD module and the response to inquiries.
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- Excellent organizational communication, facilitation and interpersonal skills in a cross-functional team.
- Demonstrated ability to manage timelines and keeping quality of work.
- Working knowledge of a document management system.
- Skills to appropriately manage CROs or translation vendors.
- Skills to read scientific documents in English and communicate with the global members both in English.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
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BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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R1600880 : Manager, Expert Scientific Writer
