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.

• Prepares, review and coordinates local regulatory submissions (Medsafe, HDEC, 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 (Medsafe &/or HDEC) to internal clients.

• Develops and implements local submission strategy. Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.

• Serves as the 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 quickly.

• 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 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 Start up locally to ensure the local submission activity is planned and delivered in accordance with the global project submission strategy.

• Develops country specific Patient Information Sheet/Informed Consent form documents.

• Negotiates grant budgets(s) and payment schedules with sites in conjunction with investigator grant analysts/sponsor.

• 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 Start up activities are accurately maintained in the database and is current at all times.

• Is responsible for country study files and ensures that they meet PPD SOP'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 SIA 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.

• Dual role

• Lead CAS

• All amendments

• Country SMEs

• Phase 1/EDS studies

• Advanced cell therapies

• GMOs

• Secondment ready

• Identifies process improvements and assists with job aid updates and delivering team training.

• 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

• Standout colleague with teambuilding skills

• Basic organizational and planning skills

• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations

• Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Frequent mobility required.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts to obtain or relate information to diverse groups.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits including company paid private health insurance and risk benefits insurance (via selected company provider), wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.

• Flexibility: Balance your work and personal life with flexible arrangements.

• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.

• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.

• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.