Work Schedule

Standard (Mon-Fri)

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.

Location/Division Specific Information

This is a home-based position.

Discover Impactful Work:

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

A day in the Life:

• 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 (in collaboration with the local regulatory manager for sophisticated issues) 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 to ensure submissions are managed in a timely manner.
• 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; 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 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.

Keys to Success:

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 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.

Knowledge, Skills, 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 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