Procedural Document Manager
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Expected Areas of Competence/Responsibilities:
- Ability to lead in the development of Procedures to manage risk identified by the business in a GxP Quality Management structure.
- Ability to lead in review of current processes as documented with a compliance/regulatory mindset to identify key gaps and risks that SME teams need to remedy during the writing process.
- Ability to drive consensus, drive performance and to lead strategically
- Able to effectively manage projects, escalate issues as necessary and identify/meet key milestones
- Knowledge of GxP (GCP, GLP, and GMP) along with ICH Guidelines, ISO 9000, and CFR21
- Ability to work with various levels of management and global staff to ensure compliance with BMS internal processes while negotiating and influencing solutions without direct authority
- Ability to review business processes and identify where enhancements need to be made for efficiency
- Organizational and project management skills to provide detailed tracking of specific documents and commitments
- Effectively manage large volumes of documents
- Effectively prioritize tasks and projects in order to meet timelines
- Proactively identify issues that are creating barriers and offer solutions to fix the problems, and/or streamline work
- Ability to initiate and learn independently and share learnings with others
- Establish strong working relationships with key internal stakeholders and business partners
- Ability to work autonomously, and know intuitively when to seek assistance or guidance
- Ability to think about solving problems through other mechanisms besides procedural documents (i.e., training, system capabilities)
- PhD with 3-6 years' experience working in a pharmaceutical or highly regulated environment, Master's degree with 4-8 years' experience, Bachelor's degrees with 8-10 years' experience
- Project Management skills
- Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
- Demonstrated ability to maintain a high level of productivity, accountability, and positive energy
- Document Development and Review
- High level of compliance writing competency, specifically in appropriate use of grammar, syntax, and organization of ideas with a scientific focus
- Provide close attention to detail through proofing and quality control
- Flexible thinker with a growth mindset
- Proactively use judgement and creativity to manage risk and uncertainty, and anticipate the need for and implement contingency or escalation plans
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.