Country Approval Specialist

At Thermo Fisher Scientific,you’lldiscover 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,cleanerand safer. We provide our teams with the resources needed to achieve individual career goals while taking science a stepbeyond throughresearch,developmentand 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 tomonitoringthrough 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.

Discover Impactful Work:

As a Country Approval Specialist, you will support studystartupbyparticipatingin the management and preparation,reviewand coordination of country submissions in line with global submission strategy. 

A day in the Life:

• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC,additionalspecial national local applications if applicable,e.g.gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.

• Provides, underguidancelocal regulatory strategy advice (MoH &/or EC) to internal clients.

• Provides project specific local Startup services and coordination of these projects.

• May have contact with investigators for submission related activities.

• Key-contact at country level for either Ethical or Regulatory submission-related activities.

• Coordinates, under guidance, 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.

• Achievescompany’starget cycle times for site.

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

• Mayassistwith grant budgets(s) and payment schedules negotiations with sites.

• Supports the coordination of feasibility activities, asrequired,in accordance withagreed timelines.

• Enters andmaintainstrial status information relating to Startup activities onto company tracking databases inan accurateandtimelymanner.

• Ensures the local country study files and filing processes are prepared, setupandmaintainedas per company WPDs or applicable client SOPs.

• Maintains knowledge of andunderstandcompany SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Keys to Success: 

Education

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

Experience

• Previousexperience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)

• In somecasesan equivalency, consisting of a combination ofappropriate education, training and/ordirectly relatedexperience, 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 computer skills and the ability to learnappropriate 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, asrequired

• Basic organizational and planning skills

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

Work Environment 

Thermo Fisher Scientific values the health and wellbeing 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:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary for typical working hours.

• Ability to use and learn standard office equipment and technology withproficiency.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

• May require travel. (Recruiter will provide more details.)

Benefits

We offer competitiveremuneration, annual incentive plan bonus, healthcare, 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!

Our Mission is to enable our customers to make the world healthier,cleanerand safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technologicalinnovationand support patients in need. #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 discriminateon the basis ofrace, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status,disabilityor any other legally protected status.

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