ESR Governance Specialist, OBU Medical Affairs

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 demanding situations because we are committed to doing the right thing.  We put patients first and follow the science to bring life-changing medicines to patients that need them.  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.

AstraZeneca’s Oncology portfolio includes Company Sponsored Observational and Interventional Research, Externally Sponsored Research (ESR) and Early Access Programs (EAP).

As an ESR Governance Specialist, within the Oncology Business Unit Medical Innovation, Strategy, and Operations Team at AZ you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing practice and patients’ lives. You will support evidence generating activities according to specific processes to help secure Oncology portfolio deliverables to time, cost, and quality. This role will report directly to the Senior Director, Project Management Office and be based in Mississauga, Canada.

Accountabilities/responsibilities

• Maintain tracker and provide status updates of all ESR submissions for specific Tumor Area into ESR study management system from time of initial proposal through approval of protocols and amendments
• Maintain ESR Management System record for study, and initiate workflows for proposal, protocol and amendment reviews as needed
• Collaborate with Local and Global teams to triage proposals and ensure appropriate risk classification is assigned
• Provide administrative support as needed towards the review of ESR submissions that enables timely and consistent approach to evaluation
• Partner with Tumor Project Manager to facilitate monthly ESR Review Committee meetings (pre/post meeting material collection and dissemination, agenda preparation and communication, taking/publication of meeting minutes, etc.)
• Follow up with ESR Review Committee members for all necessary actions in a timely manner
• Update ESR Strategies and Areas of Interest on appropriate internal and external websites in collaboration with Corporate Communications & Compliance
• Where required, input into functional work including training activities and development of procedures and templates
• Provide subject matter expertise into process, tools and systems where required

Culture

• Encourage a vibrant, entrepreneurial and externally facing team focused on the delivery of successful projects and programs that support courageous leadership, innovation and collaboration
• Collaborate strongly with other Project Leaders to embed best practice
• Flexible mindset and dedication to efficient productivity

Required experience:

• Bachelor’s degree in biological science or healthcare-related field
• Experience of effective working in a multi-cultural, matrixed environment
• Experience working in a global setting, managing stakeholders within different time zones
• Excellent written and verbal communication skills as well as proven collaboration and organizational skills
• Excellent knowledge of spoken and written English
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
• Strong interpersonal skills and ability to work in a team environment
• Demonstrate concern of standards, concern of impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control and tenacity
• Willingness and ability to train others when needed
• Demonstrate ability to work independently, as well as in a team environment
• Experience using systems and tools

Preferred Requirements:

• Knowledge of the clinical study and drug development processes, GCP/ICH guidelines and general understanding of the development/commercialisation of pharmaceutical products
• Six Sigma Medical/Process Excellence and/or Project Management/PMP/FPX certification is a plus but not required
• Depth of understanding of medical, scientific and/or commercial pharmaceutical marketplace of Oncology

Knowledge/Skills/Competencies

• Skilled in process development and implementation, organizational effectiveness, and communication
• Able to deliver high quality work outputs despite ambiguity or a constantly evolving environment
• Delivery focus with an ability to be responsible for and manage multiple project deliverables in very short timelines
• Strong interpersonal skills with an ability to flex styles dependent upon the situation
• Ability to pull together diverse teams over whom they have no line management responsibility in a matrix environment (i.e. ability to influence and drive for results)
• An excellent communicator; evidence of strong independence and innovative seeker of strategic solutions; forward looking