Procedural Document Manager

Profile

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)

Qualifications:

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com