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Country Approval Specialist


PPD is recruiting for our growing Australian study start-up team. As one of the world's largest CRO's, our CRA's have the opportunity to work on challenging projects across a wide range of therapy areas with some of the most innovative pharmaceutical and biotech companies in the world PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading company amongst CROs and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO.

Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company. Currently we are recruiting for a dual role for Country Approval Specialist/Contract Specialist. Role duties: - Provides Site Selection support for awarded multi-service projects - 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 - Prepare, review and coordinate the local regulatory submissions (MoH, EC, additional special national local applications if applicable, import licenses etc) in alignment with the global submission strategy. - Developed collaborative relationships with investigative sites and client company personnel. - Negotiate and finalize site contracts and budgets as necessary - Maintain regular site contact during the start-up phase and document all communications in CTMS.

- Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process - Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes. Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 to 2 years') or equivalent combination of education, training, & experience. - Australian or New Zealand site knowledge advantageous Knowledge, Skills and Abilities: - General understanding of budget negotiations within Australia - Basic understanding of contract and Indemnification requirements for Australia - Effective oral and written communication skills - Excellent interpersonal skills - Strong attention to detail and quality of documentation - Good negotiation skills - Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations Our offer:.


Date09 March 2023

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