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.

Location/Division Specific Information

• Our dedicated teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

• Home base and preferably located in Melbourne, Sydney or Brisbane.

Discover Impactful Work:

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

A day in the Life:

• Prepares, review and coordinates 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.

• Provides local regulatory strategy advice (MoH &/or EC) 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 primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex 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 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 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 recognising 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.

• Directs/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

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

• Previous relevant study start up experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).

• Therapeutic experience in Oncology essential

• Phase I experience essential

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

• 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 supervision, 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

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• 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.

• Australian citizenship or permanent residency required

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 purchaseadditional 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 W GEA Employer of Choice for Gender Equality

We offer competitive remuneration, annual incentive plan bonus, 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

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.