- Lead the authoring of clinical/regulatory documents (protocol, briefing book, clinical study report, CTD 2.5, CTD 2.7.3&4) and support the performance goals (including quality and timeline) for filing regulatory dossiers in China as planned by the R&D Development Teams. In addition, make challenging proposals from the viewpoint of writing strategies and processes depending on the situation, and lead the team.
- Establish cross-divisional cooperative partnership with other functions and lead to more efficient process development, according to the optimized and standardized processes and systems.
- Fulfill the role of Manager, China Scientific Writing and support the less experienced writer
- Input&review the storyboard to author regulatory dossier policies and align with global team based on the information provided by DT and make challenging proposals from the viewpoint of writing strategies according to the situation.
- As Manager, China Scientific Writing, 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. In addition, make challenging proposals from the viewpoint of the process depending on the situation and shorten the target timeline.
- Propose to the team the optimal strategy for preparing regulatory submission documents and lead the process improvement based on the tendencies of each review division concerning the contents of NMPA review reports and inquiries.
- Complete the clinical modules with cross functions 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 reliability survey.
- Manage the operational execution by strategically using outsource vendors and ensuring quality 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 cross-functional business process improvements based on information from collected metrics.
- As a senior scientific writer, give advice to other scientific writers to help them improve their capabilities in creation of clinical/regulatory documents for China. Also, provide guidance and support to the inexperienced writer.
- Provide additional value by creating better collaborative work environment internally and externally to ensure that China team has a good communication with HQ counterparts as well as key stakeholders, such as clinical research and regulatory.
- Good communication with Global Scientific and Regulatory Documentation (GSRD) leadership team to facilitate collaboration with GSRD in China submission.
- Give advice to members in our organization from the viewpoint of scientific writing even for irregular applications and types of applications /consultations that have not been experienced before
- B.S. in medical / pharmaceutical / veterinarian / life-science area or 5 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 5 years (MS) to 8 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.
- Deep understanding of the tendency of each review department of NMPA regarding the contents of review reports and inquiries. And can flexibly improve the contents/process of regulatory documents.
- Demonstrated ability required for excellent writing skills both in Chinese and in English, preferably in authoring and leading the production of clinical/regulatory documents for submission to NMPA.
- Have ownership and the ability to find challenges within the organization and propose and lead process improvements, etc.
- Ability to analyze and interpret complex data from a broad range of scientific disciplines and adapt it to document development and process improvement.
- Capable of advising the risk of filling based on the data and having other options to avoid or minimize them as an expert of scientific writer
- 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 vendors.
- Skills to read scientific documents in English and communicate with the global members in English.
- People management skill
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Manage, Scientific Writing - Beijing, 中国 - Bristol Myers Squibb
描述
Description
Leads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in China. Provides support for fit-for-purpose regulatory documents to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline.
Position Summary
Position Responsibilities
Degree Requirements
Experience Requirements
Key Competency Requirements
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through scienceTM ", 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 . Visit 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
