Ctry Approval Spec

Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.

Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:

Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.

Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients.

Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times.

Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.

As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites.

You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

A day in the Life:

• 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.
• Keycontact at country level for either Ethical or Regulatory submissionrelated activities.
• Coordinates, under guidance, with internal functional departments to ensure various site startup 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 startup 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 provided.
• Exercises judgment within defined procedures and practices to determine appropriate action. Business Contacts are primarily internal to the company with infrequent external customer /
• Relationships vendor contact on routine matters.
• Builds productive internal / external working relationships.

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, 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

Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspect

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