Global Submission Manager

Cambridge, MA

Contract

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OVERVIEW

At Advanced Clinical, we’re excited to share with you a great opportunity at a growing organization committed to clinical excellence for the position of Global Submission Manager. The Global Submission Manager is located in Cambridge, Massachusetts and is accountable for the timely delivery of compliant global submissions. This position promotes a global e-working environment and drives efficient, standardized best practices for regulatory submission document management. As they partner with the Global Regulatory Lead, this role will create and execute the submission strategy to introduce efficiency by promoting re-use of documents, adopting global dossier principles, and standardizing processes.

RESPONSIBILITIES

  • Oversee the local Global Submission Managers, 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
  • Partners with GSM Global Lead to identify resourcing needs and appropriate allocation of GSMs to projects 
  • Manages the cross-functional submission team in the delivery of compliant submission components
  • Leads a global/local publishing team to coordinate timely, compliant submissions, prepared for global regulatory agencies
  • Sets the submission publishing strategy, including timelines and resource projections
  • Maintains a 2-year submission projection for functional planning
  • Ensures the publishing strategy maximizes document re-use and introduces efficiencies and learnings from other project and accounts for other planned registration activities
  • 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
  • Ensures the project team has sufficient awareness and understanding of eCTD principles and lifecycle management
  • 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

EXPERIENCE

  • Experience working within Regulatory Operations environment and understanding of submissions publishing process and requirements, in a pharmaceutical industry setting 
  • Comprehensive document management experience  
  • Experience in developing and implementing novel technological solutions or new processes and leading change implementation
  • Qualified project management experience
  • Experience introducing new systems and procedures based on interpretation and application of regulatory agency guidance documents and mandated legislation such as eCTD
  • Fluent with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission

EDUCATION

  • Master’s Degree required

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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