Regulatory Compliance Analyst

2 weeks ago

Sunrise Manor, Nevada, United States Synergistix Full time
Company Overview: Since its inception in 1997, Synergistix has been dedicated to attracting skilled professionals in the realms of software development and CRM solutions. As we expand and diversify, we take pride in fostering an exceptional company culture that offers a range of exciting opportunities and career paths for committed individuals. If you are enthusiastic about a fulfilling career in the expanding global Life Sciences sector, we would be delighted to hear from you. To discover more about Synergistix, visit our website.

Why Work With Us? Our culture emphasizes collaboration and teamwork, prioritizing collective success over individual achievements. We value honesty and integrity as fundamental components of our success, alongside our innovative offerings. We seek individuals who are passionate about technology, customer service-oriented, team players, and eager to learn and share knowledge. By becoming part of our team, you will thrive in a supportive and collaborative work environment.

Position Summary:
The Regulatory Compliance Analyst will be instrumental in ensuring compliance throughout the organization. This role involves supporting customer audits and adhering to relevant legislation and pharmaceutical industry standards. Furthermore, the Analyst will provide essential guidance and training related to the development of documentation and internal controls.

Key Responsibilities:
  • Oversee critical functions of the compliance program.
  • Conduct intake and monitoring for significant departmental activities.
  • Facilitate communications to reinforce compliance and vendor management processes.
  • Execute compliance reviews and establish/monitor corrective action plans as needed.
  • Analyze deviation reports and CAPA management activities, ensuring appropriate actions are taken.
  • Evaluate the company's products and services to ensure compliance with federal and local regulations.
  • Assist with client audits and support the creation and implementation of corrective actions to maintain compliance with customer specifications.
  • Coordinate Governance, Risk & Compliance meetings and document meeting minutes.
  • Collaborate with internal teams to initiate changes based on new or updated legislation, systems, or procedures.
  • Maintain awareness of the business context and company profitability, including budgetary considerations.
  • Perform additional duties and special projects as assigned.

Qualifications and Skills:
  • To excel in this role, candidates must effectively perform each essential duty. The requirements outlined below represent the knowledge, skills, and abilities necessary for success. Reasonable accommodations may be made for individuals with disabilities.
  • Adherence to all personnel policies.
Education, Experience & Technical Skills:
  • A Bachelor’s degree or higher in a related field is strongly preferred, though proven work experience may be considered in lieu of a degree.
  • A minimum of three years of compliance-related experience is required, or at the discretion of management.
  • Experience in a regulated organization is essential (pharmaceutical experience preferred).
  • Background in consulting, corporate compliance, legislative review, or project management is advantageous.
  • Experience in the pharmaceutical or life sciences sector is preferred.
Soft Skills:
  • Self-motivated, assertive, and capable of working independently in a dynamic environment.
  • Ability to effectively manage multiple priorities.
  • Outstanding customer service and relationship-building skills.
  • Excellent verbal communication abilities.
  • Strong written communication skills.
  • Creative and adaptable problem-solving skills in a changing work environment.
  • Detail-oriented with sound decision-making capabilities.
  • Strong organizational and collaborative skills are essential.
Benefits of Working at Synergistix: Synergistix provides a comprehensive benefits package that includes:
  • Comprehensive health plans with generous company contributions for employees and their dependents.
  • 401k plan.
  • Dental and vision insurance.
  • Supplemental and gap insurance plans.
  • Short and long-term disability insurance.
  • Fully company-paid life insurance (with options to buy up).
  • Life insurance plans for spouses and children.
  • Up to five weeks of paid time off (PTO).
  • Paid time off during the month of your birthday.
  • Paid time off during your service anniversary month.
  • Flexible work schedules.
  • Telecommuting options for qualifying positions.
  • Casual dress code five days a week.
Synergistix Values Its Employees: At Synergistix, we prioritize our employees' career development while ensuring a challenging work environment. We demonstrate our appreciation for our employees through various perks, including:
  • Annual Employee Appreciation Day.
  • Monthly Town Hall Meetings.
  • Celebrations for birthdays and service anniversaries.
  • Family-friendly events such as our Annual Company Picnic and Holiday Celebration.
  • Bagel Fridays.
  • A game room.
  • Dry cleaning services.
  • Monthly appreciation events.
  • And much more.
About Synergistix:

Since 1997, Synergistix has been at the forefront of driving the commercial success of Life Sciences companies by enabling them to cultivate strong customer relationships and build effective sales teams. Additionally, Life Sciences companies rely on Synergistix for our sample accountability services and sample management support. As we continue to grow and diversify, we are proud to offer an extraordinary company culture with a variety of exciting opportunities and career paths for dedicated professionals.

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