Procedural Documentation Manager
- Princeton, NJ
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
This job supports Global Submission Management (GSM) through development and oversight of Procedural document activities.
- Primary oversight for the development and lifecycle management of Global Submission Management procedural documents.
- Provide support, as needed to GSM SME's for Procedural Document creation/review.
- Manages GSM processes, procedures, and templates
- Manage the timely scheduled review of GSM Procedural Documents
- Leads effort to consolidate heritage operating company procedures
- Leads effort to create new procedures, when needed
- Supports BMS enterprise quality Management activities and initiatives
- Provide support for all audit activities related to GSM. Learn the BMS Quality Management system to be able to function as BMS Liaison when audits involve Vendors.
BA/BS degree, science / technology field preferred experience
- 5+ years relevant pharmaceutical experience. Procedural writing experience preferred.
- 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
Key Competency Requirements
- Preferred demonstrated experience in procedural writing
- MS Office Suite
- 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.
- Strong communication skills, written and verbal with a strong customer focus.
- Work independently by demonstrating ability to think in a logical and decisive manner. Independently follows up and resolves outstanding issues.
- Strong understanding of essential deadlines and prioritization.
- Innovative, proactive, and motivated, with a focus on continuous improvement and a strong desire to succeed.
- High attention to detail
- Able to effectively manage projects, escalate issues as necessary and identify/meet key milestones
- Ability to work with various levels of management and stakeholders to ensure compliance with BMS internal processes while negotiating and influencing solutions without direct authority
- Organizational and project management skills to provide detailed tracking of specific documents and commitments
- 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
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
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