Associate Director, Submission Enablement
Location:
Gaithersburg , Maryland
Posted:
December 16, 2017
Reference:
R-014517
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As an Associate Director, Submission Enablement in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
The Associate Director, Submission Enablement directs the enablement and support activities of the submission and clinical document publishing teams. The submission and document publishing teams are responsible for the management, compilation, publishing, delivery and archiving of global regulatory documents and submissions. Contributes to the strategy, direction, and efficient operation of the global GRO skill group.  Ensures that GRO subject matter experts (SMEs) can meet business demand from global drug project teams. 
Main Duties and Responsibilities
As the Associate Director of Submission Enablement you will provide guidance and expertise to the submission and document publishing enablement teams, which includes business administration of submission management systems, subject matter experts and business processes that govern the compilation, publishing, submission and archival of regulatory documents and submissions.  You will monitor the environment for changes in legislation related to submission and document management, introduces standards, best practices and quality control procedures. You will ensure submission formatting requirements are incorporated within AZ Regulatory systems via involvement in development of requirements, processes, standards; validation and implementation; support for new systems and system enhancements. Activities include evaluation testing, creation and dry-run of scripts, performing user acceptance testing (UAT) and operational qualification (OQ) scripts, updating process documentation.
You will lead or participate as a member of GRO and/or cross-functional change teams, providing expert advice. You will analyze resource needs, identifies potential resource shortages and mitigates risks.  You will work with line management to recommend allocation of resources in accordance with portfolio prioritization and document delivery requirements across GRO.  You will ensure engagement with clinical alliance partners to enhance delivery quality.  You will liase with regulatory system governance and e-submission requirement bodies/organizations within AstraZeneca.  You will engage with process development efforts and organizational bodies related to document and submission publishing procedural documents, toolkits and other guidance.  You will lead change projects and related activities. You will be responsible for: Publishing Access Management - define and implement processes for access to publishing systems, viewing tools, gateways, validators, file shares. Training - In cooperation with publishing system governance bodies, assess needs for initial training (access-related) and business process-specific training.  You will take business ownership of case management system(s) related to user queries of submission and document publishing systems and be the process owner for the usage of case management tools.
Essential Requirements
  • BS degree
  • Experience in pharmaceutical/medical industry
  • Proven change management experience
  • Proven experience in developing and setting strategy for submission publishing
  • Strong analytical and critical thinking ability
  • Comprehensive knowledge of pharmaceutical drug development process
  • Good understanding of current regulatory legislation, guidelines and trends relating to regulatory submission management (process, tools, standards)
  • Experience in developing and implementing new systems and processes
  • Able to manage productivity responsibilities
Desirable Requirements
  • Manages change with a positive approach to the challenges of change for self, indirect team members, and the business.  Sees change as an opportunity to improve performance and add value to the business.
  • Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
  • Good problem and conflict resolution skills.
  • Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment.
  • Ability to innovate best practice with business process analysis and design
  • Ability to thrive in a rapid paced environment
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer.  AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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