PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
Post : Country Approval Specialist
Job Description
• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPD’s target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Candidate Profile
• Bachelor’s degree in a science related field or Pharmacy graduate or equivalent certification / licensure. Or an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.
• Prior experience in Startup will be important.
• Along with the core responsibilities of CAS, the person should be willing to learn and perform additional startup activities - handling budgets/Contracts, feasibilities, pre-study visits. Willing to travel (~ 20% of work).
• Previous experience as a CRA - monitoring, pre study assessment visits will be added advantage though not mandatory.
• Ability to work under dynamic environment, multitasking and flexibility will be crucial.
Additional Information
Qualification : B.Pharm
Location : Maharashtra-Mumbai
Industry Type : Pharma
End Date : 30th October, 2018
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