Astrazeneca

Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation

Diagnostic Executive is to work in appropriate coordination with the Field Sales Team and Medical Scientific Liaisons to help executing tactical plans with a deep understanding of the medical environment and disease.

Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.

Ensure team members are trained and competent in all delivery areas. Assist the team during high work volumes by completing LTO accountabilities. Apply scientific knowledge to create compelling medical content and communications.

Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report.

Plan, execute & ensure timely submission of various applications when assigned including but not limited to only these: test license application, HAQ response submission, CT updates and notification submission e.g. IB amendment, site closure, site addition, EC approval submission etc.

Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical, scientific content through utilizing the correct channel mix, which will differentiate AstraZeneca products from those of other companies.

Ensures that direct reports have development and training plans, according to IDP process. Coaches the direct reports on a regular basis, and plans, organizes coaching with external providers if needed.

Support DM Delivery Leads to maintain CDM specified systems and types of deliverables, milestone achievements, risks and mitigations and data transfer agreements, and other study administrative needs.