Country Approval Specialist

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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.

Position Overview:

As a Country Approval Specialist you will manage the preparation review and coordination of Country Submissions in line with global submissionstrategy.

Essential Functions:

• Prepares review and coordinates local regulatory submissions (MoH ECadditional special national local applications if applicable e.g. gene therapyapprovals viral safety dossiers import license) in alignment with globalsubmission strategy.
• Provides local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develops and implements local submission strategy. Provides technical expertiseand coordination oversight for projects in collaboration with relevant internaldepartments.
• Serves as primary contact for investigators and with the local regulatoryauthorities (in collaboration with the local regulatory manager for complexissues) to ensure submissions are managed in a timely manner.
• Ensures guidelines and processes are followed for effective internal PPD teamcommunications as well as communications with investigators and with thecountry regulatory authorities to ensure submissions are managed in a timelymanner.
• Acts as a key-contact at country level for all submission-related activities.
• Participates as required in Submission Team Meetings Review Meetings andProject Team meetings.
• Coordinates with internal functional departments to ensure various site start-upactivities are aligned with submissions activities and mutually agreed upontimelines; ensures alignment of submission process for sites and study arealigned to the critical path for site activation.
• Achieves PPDs 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 anddelivered in accordance with global project submission strategy.
• Develops country specific Patient Information Sheet/Informed Consent formdocuments.

Education Experience and Requirements:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to3 years).

In some cases an equivalency consisting of a combination of appropriate education trainingand/or directly related experience will be considered sufficient for an individual to meet therequirements 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 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 ECregulations

Why Join Us:

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

What we offer:

As well as being rewarded a competitive salary we have an extensive benefits package based around the health and well-being of our employees. We have aflexible working culture where PPD clinical research services truly value a work-life balance. Weve 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 organization but with a local feel.

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 100000 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 with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

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.