Ctry Approval Spec - Buenos Aires, Argentina - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Buenos Aires, Argentina

hace 1 semana

Publicado por:

Sofía Rodríguez

beBee Recruiter

Descripción

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients.

Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times.

Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.

As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites.

You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Responsibilities:

Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
Provides project specific local SIA services and coordination of these projects
May have contact with investigators for submission related activities
Keycontact at country level for either Ethical or Regulatory submissionrelated activities
Coordinates, under guidance, with internal functional departments to ensure various site startup 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 startup 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
Entes and maintains trial status information relating to SIA 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

Grow your career as a Senior Country Approval Specialist, a Feasibility Specialist, or a Site Contract Specialist - all supporting site activation.

You could move into the country management career track, managing a country or groups of countries for site activation. Or, pursue other paths within our Global Clinical Development group. These are just a few career pathways available once you chose to Be with PPD.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

What To Expect Next

Qualifications

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to2+ years)

Knowledge, Skills, and 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
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
PPD 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:
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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 and/or standing for typical working hours
Able to lift and move objects up to 25 pounds
Able to work in nontraditional work environments
Able to use and learn standard office equipment and technology with proficiency
May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments
Able to perform successfully under pressure while prioritizing and