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Country Approval Specialist - Study Start-up Specialist (SSU)

PPD is recruiting for our growing Australian study start-upteam. As one of the world's largest CRO's, our CRA's havethe opportunity to work on challenging projects across a wide range of therapyareas with some of the most innovative pharmaceutical and biotech companies inthe world

PPD is proud to employ over 20,000 employees worldwide, across 47countries and 89 offices. In just over 30 years, PPD has grown to become aleading company amongst CROs and recently has won accolades for industryleading CRA team, employee training & development, excellence in serviceand numerous awards for Best CRO. Our sustained year on year growth means thatwe 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:
  • ProvidesSite Selection support for awarded multi-service projects
  • Key-contactat country level for either Ethical or Regulatory submission-relatedactivities.
  • Coordinates,under guidance, with internal functional departments to ensure various sitestart-up activities are aligned with submissions activities and mutually agreedupon timelines; ensures alignment of submission process for sites and study arealigned to the critical path for site activation
  • Prepare,review and coordinate the local regulatory submissions (MoH, EC, additionalspecial national local applications if applicable, import licenses etc) inalignment with the global submission strategy.
  • Developedcollaborative relationships with investigative sites and client companypersonnel.
  • Negotiateand finalize site contracts and budgets as necessary
  • Maintainregular site contact during the start-up phase and document all communicationsin CTMS.
  • Drafts,reviews, negotiates and finalizes agreements with study sites in accordancewith local/accepted process
  • Negotiates within approvedparameters both investigator grant budget negotiation parameters, contractualterms and conditions in accordance with company contractual considerations,client contractual considerations, established process with sites and followsestablished escalation routes.

Job Qualification:

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 : As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company. At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position.

Locations we are hiring in:
  • Office based Melbourne, Australia
  • Home based Australia
  • Home based New Zealand


Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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