Sr Compliance Specialist

PPDI (América, Argentina) Publicado hace 7 horas

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our colleagues in corporate strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

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.

As a Senior Compliance Specialist, you will execute compliance and quality strategies within the organization. (note: deleted examples as not applicable, moved them to 5th bullet below)

Summarized Purpose:

Executes quality and compliance strategies and initiatives across the organization. Manages the tracking and reporting of quality and compliance activities. Maintains tools and materials, serves as project lead, and provides mentoring and expertise to advance the vision of the department.

Essential Functions:

  • Researches and addresses issues, tracks metrics and maintains reports and documentation related to quality standards and intelligence activities.

  • Collaborates with global investigator services and project delivery in providing quality input to clinical trial investigator related accounts and contacts.

  • Provides QA input to Requests for Information and Master Level Service Agreements and consults with subject matter experts within QA when necessary.

  • Leads smaller projects and/or some process/quality improvement initiatives.

  • Communicates with representatives within the department to ensure quality and timelines are maintained with respect to compliance activities (e.g., internal process audits, standard language/templates, and QMS documents).

  • May lead or participate in group projects or process improvement initiatives.

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 to 5+ years).

Knowledge, Skills and Abilities:

  • Excellent oral and written communication skills

  • Strong organizational and time-management skills

  • Extensive knowledge of the clinical trial process

  • Comprehensive knowledge and understanding of ICH GCP and other relevant regulations and guidelines

  • Demonstrated problem solving skills

  • Demonstrated critical thinking skills

  • Excellent attention to detail

  • Strong computer skills: ability to learn and become proficient with appropriate software

  • Demonstrated ability to multitask and prioritize competing demands/workload

  • Proven flexibility and adaptability

  • Proven ability to conduct process audits

Working Environment:

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:

  • 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 with proficiency.

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

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

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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.

Internal description and qualifications are the same

Organization: Quality Assurance and Complian

Primary Location: Latin America

Other Locations:

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