Counsel
Syneos Health
full-time
Posted on:
Location Type: Hybrid
Location: Buenos Aires • Argentina
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Tech Stack
About the role
- Provide legal and regulatory support on LATAM/global clinical development and commercialization matters, including quality-related GxP issues, under the guidance of senior attorneys
- Advise internal clients on drug and medical device laws, regulations, and GxP standards, including but not limited to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) as well as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) as they relate to clinical research
- Provide legal support for communications with LATAM and other regulatory agencies
- Contribute to compliance investigations and assist with resolution of regulatory and operational issues
- Advise on laws focusing on advertising and promotion, patient support, payer access, and go-to-market strategies
- Provide legal support to Dispute Resolution team on litigation and pre-litigation matters
- Monitor and summarize legislative and regulatory developments that may impact the company or its clients
- Collaborate across the Legal department, including the Company’s global team of regional-based attorneys, on process improvements and cross-functional projects
- Support the Syneos Health ‘Mission, Vision and Values.’
Requirements
- Fully qualified lawyer
- Two to four years of experience advising on regulatory and compliance matters in the biopharmaceutical, healthcare, or life sciences sector (CRO, biotech, or pharma experience preferred)
- Understanding of statutory and regulatory frameworks governing the development, approval, and marketing of drugs and medical devices
- Strong ability to analyze and communicate complex legal and regulatory concepts clearly and concisely, while providing pragmatic advice to help the business achieve its goals while mitigating legal and regulatory risks
- Demonstrated ability to work independently on assigned projects while contributing to collaborative, cross-functional teams
- Excellent attention to detail, strong organizational skills, and ability to manage multiple priorities in a fast-paced environment
- Eagerness to learn and constant commitment to professional growth
- Positive attitude and solutions-oriented mindset
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
legal supportregulatory complianceGxP standardsGood Clinical Practice (GCP)Good Pharmacovigilance Practice (GVP)Good Pharmacoepidemiology Practice (GPP)Good Manufacturing Practice (GMP)Good Laboratory Practice (GLP)regulatory frameworkslitigation support
Soft skills
analytical skillscommunication skillsorganizational skillsattention to detailindependent workcollaborative teamworkproblem-solvingpositive attitudesolutions-oriented mindsetcommitment to professional growth
Certifications
law degree