[Hiring] Senior Country Approval Specialist @Thermo Fisher Scientific

Role Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.

• Manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
• Prepare, review and coordinate local regulatory submissions (RA, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides local regulatory strategy advice (RA &/or EC) to internal clients.
• Develop and implement local submission strategy.
• Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serves as primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner.
• Ensure guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities.
• Acts as a key-contact at country level for all submission-related activities.
• Participates as required in Submission Team Meetings, Review Meetings and Project Team meetings.
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
• Achieves PPD’s target cycle times for site activations.
• Prepares the regulatory compliance review packages, as applicable.
• Liaise within Study Start-Up teams locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develops country specific Patient Information Sheet/Informed Consent form documents.
• Assist with grant budgets(s) and payment schedules negotiations with sites.
• Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advises relevant functions.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Ensures that trial status information relating to Study Start-Up teams activities are accurately maintained in the database and is always current.
• Is responsible for country study files and ensures that they meet PPD WPD’s or client SOP’s.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Advises/mentors other Study Start-Up individuals assigned to support projects of responsibility, as appropriate.
• Proactively identifies issues or anomalies in the regulatory process of a study, resolves or calls out as appropriate.

Qualifications

• 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 5+ 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.

Requirements

• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good digital literacy and the ability to learn appropriate software
• Good English language and grammar skills
• Good judgment and decision-making skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, with minimal direction, as required
• Ability to mentor fellow Study Start-Up team members in a positive and effective manner
• Standout colleague with teambuilding skills
• Excellent organizational and planning skills
• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations