Counsel

Description

Counsel

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.

Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities

Job Summary:

Syneos Health is seeking a motivated and detail-oriented regulatory attorney to join our Legal team. The ideal candidate will have experience advising clients on the legal frameworks governing clinical development and commercialization of pharmaceutical products.

Job Responsibilities:

• 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.'

Qualification 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.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.