Submission Manager I

About the position

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. The Manager 1 manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.

Responsibilities

• Provides advice regarding regulatory and submission requirements, dossier content, and format using in-depth knowledge of eCTD submission production.
• Supports the execution of the Global Submission Plan through collaborating with team members and vendors.
• Tracks progress of all components for submission to Health Authorities.
• Independently facilitate submission team meetings.
• Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced.
• Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections.
• Attend submission team and kick off meetings, represent SM, drive submission publishing timelines.
• Facilitate Initial IND Kick off meeting submission.
• Coordinate IND, NDA, BLA and Orphan Drug Annual Reports.
• Other miscellaneous regulatory operational activities.
• Develop/Update job aid documents for departmental process.
• May facilitate in focused projects related to their scope of work.

Requirements

• Proficient knowledge of global regulatory practices, submission guidelines and requirements.
• Identifies and resolves issues with the assistance of Sr. team members.
• Collects, collates, and integrates information for solution development, decision-making, and implementation.
• Generates alternative solutions by weighing risks and considering dependencies.
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.
• Delivers engaging and effective presentations of increasing complexity.
• Applies basic knowledge of project management methodologies, tools, and templates and assesses information needed to effectively manage projects of increasing complexity from start to finish.
• Defines project objectives, priorities, timelines, and metrics; tracks progress and communicates status; secures needed resources.
• Drives communication within the project team to ensure awareness of risks, issues, and dependencies and collaboration for effective completion of defined deliverables.
• Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives.
• Proposes and implements alternative solutions for submission and/or project related situations.
• Understand stakeholder needs, priorities, working processes, and activities and builds collaborative relationships.
• Solid understanding of desktop application software suites, including effective troubleshooting skills.
• Knowledge and experience with computer systems in an R&D environment.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.