Senior Country Approval Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

About the Role:

Join us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation. The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

What You'll Do:

• Manage 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 (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.

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

Other Important Information 

• This is a remote position, with only very infrequent office visits

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

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 125,000+ 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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.