Senior/Country Approval Specialist - Lisbon, Portugal-151403
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.
The Country Approval Associate manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
Essential Functions and Responsibilities:
- Prepare, review and coordinate, under guidance, local EC submissions in alignment with global submission strategy
- Support preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy
- May coordinate, 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 have contact with investigators for submission related activities
- May act as a key-contact at country level for either Ethical or Regulatory submission-related activities
- Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
- May assist in developing country specific Patient Information Sheet/Informed Consent form documents
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Enter and maintain trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timely manner
- Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
- Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
QualificationsMinimum Required Education and Experience:
- Bachelor's degree
- Around 2 years of related experience - EC/RA Submissions
- Alternatively CRA experience could be considered
- Strong knowledge of national and international clinical trials legislation
- 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
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Please note that only suitable candidates will be contacted.