This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Sr Compliance Specialist

Pharmaceutical Product Development (PPD)

MX-MX-Mexico City-Mexico City MX Av Insurgente

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

As a PPD CRA, you will perform and coordinate all aspects of the clinical monitoring and site management process.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Supports and executes Compliance strategies and initiatives across PPD, including facilitation of client audits in respective PPD office(s) and tracking and reporting of CAPAs, suspected misconduct incidents and other quality issues. Works independently with minimal supervision or mentoring required. Maintains client audit and CAPA tools and materials and provides any other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) department.

Essential Functions: Researches issues, tracks metrics and maintains reports and documentation related to Compliance activities and tasks. Facilitates client audits of PPD, including responsibility for preparing the relevant PPD team(s), hosting the audit, and coordinating responses and follow-up actions related to applicable audit findings. Provides input into various initiatives and participates in process/quality improvement projects on behalf of GQ&C. Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents). Mentors other less experienced Compliance staff and serves as a team lead for group projects within GQ&C.

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

As a PPD CRA, you will perform and coordinate all aspects of the clinical monitoring and site management process.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Supports and executes Compliance strategies and initiatives across PPD, including facilitation of client audits in respective PPD office(s) and tracking and reporting of CAPAs, suspected misconduct incidents and other quality issues. Works independently with minimal supervision or mentoring required. Maintains client audit and CAPA tools and materials and provides any other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) department.

Essential Functions: Researches issues, tracks metrics and maintains reports and documentation related to Compliance activities and tasks. Facilitates client audits of PPD, including responsibility for preparing the relevant PPD team(s), hosting the audit, and coordinating responses and follow-up actions related to applicable audit findings. Provides input into various initiatives and participates in process/quality improvement projects on behalf of GQ&C. Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents). Mentors other less experienced Compliance staff and serves as a team lead for group projects within GQ&C.

Education and Experience: Bachelor’s degree in a scientific or related discipline 6 years of clinical drug development experience including 3 years clinical operations or quality management experience in the pharmaceutical industry and/or CRO Or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities.

Required Knowledge, Skills and Abilities: Excellent oral and written communication skills Solid organizational and time-management skills Extensive knowledge of the clinical trial process Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines Effective problem solving skills Strong attention to detail Ability to work independently as required Strong computer skills; ability to learn and become proficient with appropriate software Able to multi-task and prioritize competing demands/work load Proven flexibility and adaptability

Working Conditions and Environment: Long, varied hours Work environment includes various PPD offices Multi-tasking environment Must pay constant attention to detail Interaction with internal and external clients Exposure to high pressure situations where intense concentration is needed Frequent travel may be required as business needs arise

PPD Defining Principles:

-We have a strong will to win

-We earn our customer’s trust

-We are gamechangers

-We do the right thing

-We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Education and Experience: Bachelor’s degree in a scientific or related discipline 6 years of clinical drug development experience including 3 years clinical operations or quality management experience in the pharmaceutical industry and/or CRO Or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities.

Required Knowledge, Skills and Abilities: Excellent oral and written communication skills Solid organizational and time-management skills Extensive knowledge of the clinical trial process Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines Effective problem solving skills Strong attention to detail Ability to work independently as required Strong computer skills; ability to learn and become proficient with appropriate software Able to multi-task and prioritize competing demands/work load Proven flexibility and adaptability

Working Conditions and Environment: Long, varied hours Work environment includes various PPD offices Multi-tasking environment Must pay constant attention to detail Interaction with internal and external clients Exposure to high pressure situations where intense concentration is needed Frequent travel may be required as business needs arise

PPD Defining Principles:

-We have a strong will to win

-We earn our customer’s trust

-We are gamechangers

-We do the right thing

-We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Job posted: 2021-04-13

3