Job Description

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

　　Essential Functions

　　Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.

　　Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.

　　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.

　　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.

　　Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.

　　Assists in developing country specific Patient Information Sheet/Informed Consent form documents.

　　Assists with grant budgets(s) and payment schedules negotiations with sites.

　　Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) 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.

　　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 0 to 2 years).

　　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

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.