Ctry Approval Associate (Warsaw, Poland)
PPD
PL Warsaw Warszawa PL Trinity Park III
6 d. temu

Job Description

We arevital links between an idea for a new medicine and the people who need it. Weare the people of PPD thousands of employees in locations worldwide connectedby tenacity and passion for our purpose : to improve health.

You will be joininga truly collaborative and winning culture as we strive to bend the time andcost curve of delivering life-saving therapies to patients.

Our goal-driven teams combine and deliver startup activities for the clinicaltrials, collaborating to improve processes, cycle and flexibility.

We partnerwith our sites, businesses and colleagues around the world to decrease startuptimelines and exceed expectations.

As a Country Approval Associate, you will be responsible for assisting forregulatory Country Submissions together in order to activate investigativesites.

Essential Functions :

  • Performs all administrative tasks in order to prepare, review and coordinate, 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

  • 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
  • Enters 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 provide
  • Job Qualification

    Educationand Experience :

    Bachelor's degree in life-science field

    At least 1 year experience in start-up activities

    Knowledge, Skills, and Abilities :

  • Effective oral and written communication skills
  • Excellent interpersonal skills
  • Strong attention to detail and quality of documentation
  • Good negotiation skills
  • Good computer skills and the ability to learn appropriate software
  • Good English language and grammar skills
  • Basic medical / therapeutic area and medical terminology knowledge
  • Ability to work in a team environment or independently, under direction, as required
  • Basic organizational and planning skills
  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
  • What we offer

    At PPD we hire the best, develop ourselves and each other,and recognise the power of being one team. We understand that you will want togrow both professionally and personally throughout your career, and thereforeat PPD you will benefit from an award-winning learning and developmentprogramme, ensuring you reach your potential.

    As well as being rewarded a competitive salary, we have anextensive benefits package based around the health and well-being of ouremployees.

    We have a flexible working culture, where PPD truly value awork-life balance. We’ve grown sustainably year on year but continue to offer acollaborative environment, with teams of colleagues eager to share expertiseand have fun together.

    We are a global organisation but with a local feel.

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