Manager, Expert Scientific Writer

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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.

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 a supportive culture, promoting global participation 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.

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R1596693 : Manager, Expert Scientific Writer