Senior Country Approval Specialist

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job 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. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:

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

Key responsibilities:

• Prepares, review and coordinates submissions (MoH, EC, applications if, e.g. gene therapy approvals, safety dossiers, import license) in alignment with global submission strategy.
• Provides strategy advice (MoH &/or EC) to clients.
• Develops and implements local submission strategy. Provides expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serves as primary contact for investigators and with the local authorities (in collaboration with the local regulatory manager for sophisticated issues) to ensure submissions are managed in a timely manner.
• Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
• Acts as a key-contact at country level for all submission-related activities.
• Participates as the need arises 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; 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 activations.
• Prepares the regulatory compliance review packages, as applicable.
• Liaise within SIA 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.
• May 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 advise relevant functions.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
• Oversees 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/mentos other SIA individuals assigned to support projects of responsibility, as appropriate
• Proactively identifies issues or anomalies in the regulatory process of a study, resolves or escalates as appropriate.

Keys to Success

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 5+ 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 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 SIA team members in a positive and effective manner
• Excellent team player with teambuilding skills
• Basic organizational and planning skills
• Excellent 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 perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

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