USA - Sr Global Submissions Specialist

Cambridge, MA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Global Submissions Manager in Cambridge, Massachusetts. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity

RESPONSIBILITIES

  • Promoting 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 by promoting re-use of documents, adopting global dossier principles and standardizing processes to enable simultaneous compilation and publication of submissions
  • Oversee the local Global Study Manager but with strong emphasis on global team identity and continuity in project team support
  • Identify training opportunities and provide mentoring to ensure Global Study Managers are appropriately developed in accordance with their role and responsibilities
  • Manage, develop and ensure strong performance of staff
  • Partner with Global Study Managers Global Lead to identify resourcing needs and appropriate allocation of Global Study Managers to projects
  • Responsible for ensuring appropriate Global Study Managers support on given projects
  • Manage the cross-functional submission team in the delivery of compliant submission components according to agreed timelines and processes

EXPERIENCE

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

EDUCATION

  • Minimum of Bachelor’s Degree
  • Master’s Degree preferred

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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