MedFocus Sr Global Submissions Speciali in Massachusetts

OBJECTIVES:

  • The Global Submission Manager (GSM) is accountable for the timely delivery of compliant global submissions. The position promotes a global e-working environment and drives efficient, standardized best practices for regulatory submission document management. Assigned to a specific global project and partnering with the Global Regulatory Lead, as manager of cross-functional submission team, will plan and manage regulatory submissions and author and execute submission strategy to introduce efficiencies by promoting re-use of documents, adopting global dossier principles and standardizing processes to enable simultaneous compilation and publication of submissions.

ACCOUNTABILITIES:

  • Oversee the local GSMs but with strong emphasis on global team identity and continuity in project team support.

  • Identify training opportunities and provide mentoring to ensure GSMs are appropriately developed in accordance with their role and responsibilities.

  • Manage, develop and ensure strong performance of staff.

  • Partner with GSM Global Lead to identify resourcing needs and appropriate allocation of GSMs to projects.

  • Responsible for ensuring appropriate GSM support on given projects.

  • Manage the cross-functional submission team in the delivery of compliant submission components according to agreed timelines and processes.

  • Leads a global/local publishing team to coordinate timely, compliant submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatory submission plan.

  • Sets the submission publishing strategy, including timelines and resource projections according to submission type.

  • Maintains a 2 year submission projection for functional planning, in alignment with the Global Regulatory Strategy Plan.

  • Ensures the publishing strategy maximizes document re-use and introduces efficiencies and learnings from other project and accounts for other planned registration activities.

  • Plans and manages detailed submission timelines as MS-Project schedules

  • Liaises with global and local cross functional areas in the creation of global submission ready documents and agrees dates for document handover

  • Develops a global submission tracker which specifies source submission content and tracks document approval and publishing progress against the overall submission table of contents.

  • Proactively raises any timeline concerns, risks and issues that may delay/impact the project and engages appropriate representatives to manage outcomes.

  • Understands the interdependencies among activities on a submission that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are achieved on time and to the highest quality.

  • As a global submissions expert, ensures the project team has sufficient awareness and understanding of eCTD principles and lifecycle management and understands, represents and communicates regional differences as appropriate within the context of global submission preparation.

  • Provides recommendation for formatting standards and granularity of submission documents.

  • May support the GRL in the entry of specific data in the registration tracking system.

  • May be assigned to other types of non-submission projects for e.g. name change projects.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • Bachelor’s degree

  • Extensive experience working within Regulatory Operations environment and fluent understanding of submissions publishing process and requirements

  • Comprehensive document management experience

  • Extensive experience of working within Regulatory and/or Regulatory Operations in a pharmaceutical industry experience

  • Modest first line management experience

  • Experience in prioritizing own and others workload

  • Proven experience in developing and implementing novel technological solutions or new processes and leading the implementation of change

  • Qualified project management experience

  • Fluent with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes

  • Experience in leading cross-functional teams within a matrix environment

  • Solid understanding of document management systems and concepts

  • Experience of multitasking in a dead-lined controlled and highly regulated environment

  • Master’s Degree

  • Experience of introducing new systems and procedures based on interpretation and application of regulatory agency guidance documents and mandated legislation such as eCTD.

  • Is fluent with drug development and regulatory submission process

  • COMPANY Operations - understands (or capable of understanding) COMPANY’s operating structure and methods including a good knowledge of the parent company

Please send resume to jobs@inventivhealth.com

Min Salary: $0.00

Max Salary: $0.00

State: MA