Description

For you, the sweetest success is shared success and you’re known for your good nature.

In this role, your primary focus will be to conduct External GXP/REMS audits. You will work with some of the industry’s sharpest minds and will enjoy flexibility to conduct your professional pharmaceutical and biotech audits as the lead and primary auditor. To be successful in this role, you will need to have extensive experience as the lead or primary auditor conducting external pharmacetuical quality audits such as; REMS, manufacturing, packaging, laboratory, vendor, clinical trials, pharmacovigialance, etc. and excellent communication and writing skills.

You will schedule, conduct and document assigned audits of projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to healthcare providers, pharmacies, and wholesaler-distributors, and vendors. 

Essential Requirements:

• Bachelor’s degree in the science/health care field or equivalent combined education and experience
• Strong knowledge of Risk Evaluation Mitigation Strategy (REMS) auditing including audits of healthcare providers, pharmacies, and wholesaler-distributors.
• Pharmaceutical/Clinical GxP auditing experience ( GMP, GVP, and /or GCP)  - 5- 8 years' experience
• Strong knowledge of all applicable Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) regulations and guidelines
• The ability to travel up to 15%

Desired Requirements:

• Minimum five (5) years REMS auditing experience preferred
• Experience writing audit plans and conducting virtual audits
• Experience with root cause analysis and Corrective action preventative action (CAPA) management
• Ability to identify compliance issues and convey observations in a well organized  written audit report
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
• Strong organizational, presentation, documentation and interpersonal skills with diverse cultures

The annual base salary for this position ranges from $104k to $135k. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.

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Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.