Country Approval Specialist

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.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Our Start Up Operations team is rapidly growing, and we are currently looking for a Country Approval Specialist who will be responsible for pulling regulatory Country Submissions together in order to activate investigative sites. If you have a strong attention to detail, take ownership of the accuracy of these documents while holding yourself and others accountable, then this role is right for you.

A day in the Life:

• Prepare, review and coordinate, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
• Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
• Provide project specific local start-up services and coordination of these projects
• Have contact with investigators for submission related activities
• Key-contact at country level for either Ethical and Regulatory submission-related activities
• Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation
• Achieve target cycle times for site activation
• May work with CRA(s) to prepare the regulatory compliance review packages, as applicable
• Develop country specific Patient Information Sheet/Informed Consent form documents
• Assist with grant budgets(s) and payment schedules negotiations with sites
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines
• Enter and maintain trial status information relating to start-up activities onto internal tracking databases in an accurate and timely manner
• Ensure 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 Start Up experience with submissions and contract negotiations (comparable to 2+ years) or equivalent

Knowledge, Skills, 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
• Good organizational and planning skills
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

Why Join Us?

We hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both expertly and personally throughout your career, and therefore will benefit from an award-winning learning and development programme, ensuring you reach your potential.

We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

Benefits

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, 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.

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

#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, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.