Country Approval Specialist - Study Start Up

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

This home-based position requires candidates to currently reside in Mexico.

Discover Impactful Work:

Participates in the management and preparation, review and 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, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.

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

• Provides project specific local Start Up 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.

• Achieves PPD’s target cycle times for site.

• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.

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

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

• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.

• Enters and maintains trial status information relating to Start Up activities onto PPD tracking databases in an accurate and timely manner.

• Ensures 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.

Keys to Success:

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 2+ 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

• Basic medical/therapeutic area and medical terminology knowledge

• Ability to work in a team environment or independently, under direction, as required

• Basic organizational and planning skills

• Basic 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 work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Frequent mobility required.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both inhouse 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.

• Regular and consistent attendance.

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 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 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! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

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