CMC Submission Manager
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
- Ability to work on process improvement initiatives in GDM by being an active team member recommending improvements on how GDM conducts its business day to day.
- Provides input in the review of the successes and failures of new approaches to capture lessons learned. Reviews documents to assure the regulatory guidelines and BMS processes are followed for electronic format.
- Assists in the implementation of short- and long-term goals within own workgroup within GDM. For simple CMC dossiers.
- Tracks progress and compiles reports on documentation components for simple dossiers. Interacts with responsible parties to aid in ensuring that components are received in a timely manner.
- Works closely with internal and/ or external publishing resources to ensure dossiers are completed on time. Develops and demonstrates working knowledge of global CMC regulatory requirements required and to drive submission process.
- Demonstrates flexibility to work simultaneously on multiple projects.
- Establishes and executes plans for managing workload within their assigned project(s) through efficient resource utilization and within designated timeframes.
- Effectively adjusts plans to deal with changes and obstacles. Possess ability to build CARA structures and eCTD spreadsheets to support routine/simple CMC dossiers.
- Works with authors to edit structure as it evolves.
- Ensures work is done in accordance with GDM, GRSB, GMS and R&D policies and objectives.
- Actively participates in global and regional regulatory, and project development/life cycle teams and sub teams.
- Communicates and collaborates as needed with Regulatory Liaison, GDM Submission Manager and CMC Management as needed to ensure successful outcomes for CMC submissions. Provides guidance to functional area colleagues and workgroups with regards to CMC documents, submission and dossier requirements.
- Shares their expertise and knowledge of the CMC document and dossier processes through the teaching, coaching and mentoring of various colleagues. Participates in personal development of self with supervisor by providing and asking for continuous and honest feedback.
- Embraces a healthy work environment with sensitivity to the balance between personal and professional life.
- Share expertise and knowledge through the teaching, coaching and mentoring of various members of GDM.
- Competent working in an environment that utilizes electronic doc bases, data bases, publishing systems and computer systems (Microsoft Office, Outlook, Lync/Skype, Access, Documentum, eCTD viewers and web based applications).
- Strong working knowledge of Microsoft Word (including the BMS Core Template) and Excel. Possess basic skill set to work in CARA to support CMC structures.
- Comfortable with frequent change to new software applications and procedures.
- Experience with the drug development process and possess regulatory knowledge and experience in the regulatory submission area.
- A B.S. in a relevant scientific field. Two to four years of pharmaceutical industry experience required.
- Good command of English language, both written and oral.
- Basic knowledge and understanding of the procedures and decision-making process of the Health Authorities, Industry Associations and key related institutions.
- Knowledge of BMS policies and procedures related to the drug development and regulatory processes. Working knowledge of electronic submission requirements (such as eCTD).
- Background in scientific, healthcare, or technical arena. Understanding dossier development and formatting requirements, document and dossier management.