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概要 (High-level Description; including manage team/individuals or not)

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.

役割 (Roles & 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.

必要な知識/スキル (Required knowledge/skills)

• Pharm D/Ph D/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.
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
• Demonstrated strong writing skills both in Japanese and in English, preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA.
• Ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Significant experience in authoring clinical/regulatory documents, including high-level CTD Module 2 clinical summaries, and participation in at least one major JNDA filing.
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
• 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.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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