job summary:
The GRADS Compliance Specialist contractor is responsible for executing Regulatory and PV compliance activities based on relevant regulations, procedures, and contractual requirements. Through the implementation of quality and compliance tracking tools/reports, oversight strategy, and relationship management, this role will support the development and management of continuous improvements across the Regulatory and Pharmacovigilance system, including the implementation, tracking, maintenance, and effectiveness checking of all Regulatory and PV quality system-related activities. The incumbent will support the organization and maintenance of Regulatory and PV compliance activities with metrics. Substantial focus will be placed on overseeing Regulatory and Pharmacovigilance procedural deviations, CAPA, change control management activities and inspection readiness.
location: Telecommute
job type: Contract
salary: $61.75 - 69.19 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Support investigations, development of corrective and preventative action (CAPA) and effective measures for Regulatory and PV related change controls, deviations, audits and inspections.
- Support GRADS Regulatory and/or Labeling sub-functions to enhance compliance activities with a focus on inspection readiness.
- Perform quality review of assigned aggregate reports (PSUR, PADER, REMS Assessment Report, etc).
- Support the management of Regulatory and Pharmacovigilance issues, deviations, CAPA development, and change control management.
- Collaborate with GRADS Compliance team members in executing global Regulatory and PV compliance activities.
- Identify and escalate critical quality issues to senior GRADS Compliance management.
- Support (as determined by line management) Regulatory and PV process improvements including authoring/updating controlled procedures as it relates to compliance activities.
- Assists with inspection related activities, (pre-, peri- and post-inspection).
- Remain current with global regulatory affairs, labelling and PV regulations and requirements, evaluate legislative changes affecting Regulatory, Labeling and PV, and develop strategies to support patient safety.
- Monitor the PV Compliance mailbox to ensure timely actioning of communications.
qualifications:
Required Knowledge, Skills, and Abilities
- Minimum 3 years business, pharmaceutical, or biotechnology industry experience
- Knowledge of Good Pharmacovigilance Practices (GVP) is required
- Knowledge of Regulatory Affairs and/or Labelling regulations are required
- Can apply base level quality control technical concepts and skills
- Excellent written and verbal communications skills
- Ability to work in a fast-paced environment
- Individual contributor with oversight from line manager
- Ability to work in a team environment and support stakeholder
- Ability to work across geographical boundaries
- Disciplined, detail oriented, and good time management skills
- Ability to influence or gain acceptance from others in sensitive situations
- Self-directed and ability to take action as needed with limited oversight
Required/Preferred Education and Licenses
- Bachelor's degree in business or life sciences required
- Lean Sigma certification, or equivalent certification, preferred but not required
skills: Pharmacovigilance, CAPA, Regulatory Affairs Strategy
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.