Associate Director, Submission Management

DE6633014

Associate Director, Submission Management

Bristol Myers Squibb

Summit, NJ

Less Than High School

None

Full Time, Regular

**Working with Us**Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: careers.bms.com/working-with-usWithin Submission Management, the Associate Director manages and coordinates the timely, compliant, and accurate delivery of submissions to health authorities.**Functional Area Description:** Regulatory Information and Submission Management is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and sets the strategic business direction and related processes oversight for GRS systems.**Position Responsibilities** : Leads initiative projects and other quality improvement initiatives for the department Project lead for complex development projects, as applicable for assigned projects Key player in researching for due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections Participates in the evaluation and development of business processes across the organization Participates in the Health Authority guidance and regulation updates and impact on the organization Drives the execution of the Global Submission Plan through collaborating with team members and vendors, as applicable for assigned projects Interacts with and influences responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced, as applicable for assigned projects Keeps leadership updated on changes that may impact SM processes Support of other SM members sharing expertise, providing guidance and serving as a SME Mentoring/Coaching of direct reports (People Manager) and other SM team members Other miscellaneous regulatory operational activities Develop/Update job aid documents for departmental process Act as co-lead or lead for company level initiatives and projects within their sphere of influence Sign off on IND Safety Reports submissions. (As assigned) Run reports on Book of Work/planned submissions and ensure workload is balanced within the subteam. (People Manager) Direct Report Performance/Evaluations. (People Manager) Attend and participate in submission team meetings as needed to support SM team**Key Competency Requirements** : Expert knowledge of global regulatory practices, electronic submission guidelines and requirements Anticipates and resolves complex problems/difficulties at the cross-functional level Effective written and verbal communication skills and presentation skills Ability to work independently and collaborate with upper management outside of their functional scope Ability to prioritize, manage multiple tasks and strong attention to detail Ability to make complex decisions that impact departments both internal and external Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and be technically savvy with such systems Ability to manage complex multiple projects simultaneously and meet ambitious timelines**Degree Requireme