Manager, Expert Scientific Writer

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: . 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. On-site Protocol BMS has an 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. Supporting People with Disabilities 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 . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights 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: Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1600880 : Manager, Expert Scientific Writer