Managing Counsel - Legal Regulatory GCP

Description Managing 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 Summary: Syneos Health is looking for a detail-oriented regulatory attorney to join its Legal team.
The successful candidate will be a self-starter with excellent judgment and significant experience advising clients on laws, regulations, and industry standards governing clinical development and commercialization of pharmaceutical products.
Job Responsibilities: • Responsible for providing legal regulatory advice and counsel on global regulatory and clinical development matters.
• Assists Head of Legal Regulatory with the strategy and implementation of the Legal Regulatory function in alignment with departmental and functional goals and company strategy.
• Provides legal and regulatory advice to Corporate Quality and the clinical business on quality-related issues, regulatory authority inspections, client and internal audits.
• Provides legal support to Dispute Resolution team on litigation and pre-litigation matters as appropriate.
• Advises internal teams on the application of drug and device laws and regulations, as well as 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.
• Provides legal support for communications with regulatory agencies.
• Provides legal support for compliance and quality investigations as appropriate.
• Assists Head of Legal Regulatory in advising the business on new and modified service offerings.
• Supports regulatory due diligence in connection with potential M&A or other business transactions.
• Keeps abreast of legislative and regulatory changes that may affect the company and its customers.
• Advises on regulatory and Quality Assurance commitments in clinical and commercial agreements.
• Works collaboratively across the Legal department, including the Company’s global team of regional-based attorneys, in providing legal regulatory advice, building consensus on process improvements, and driving corporate legal projects to completion.
• Supports the Syneos Health ‘Mission, Vision and Values.
’ Qualifications What we are looking for: • Fully qualified lawyer.
• 8+ years of experience advising on legal and regulatory matters in the pharmaceutical research and development space.
• Broad understanding of the clinical trials regulatory framework, with awareness of key differences across international jurisdictions.
• Strong working knowledge of GxP requirements applicable to clinical research, with a particular focus on GCP and GVP.
• Ability to communicate clearly, concisely, and professionally with all levels of management regarding complex regulatory issues.
• Experience working in a healthcare or life sciences company, such as a CRO, biotech, or pharmaceutical drug development company.
• Ability to work independently while being able to contribute successfully to cross-functional teams.
• Independent judgment, attention to detail, a desire to learn, and an ability to take on and prioritize a wide variety of complex matters in a fast-paced environment.
• Can-do attitude, ability to work under pressure and to manage the expectations of clients.
• Creative problem-solving ability with a focus on achieving client-friendly solutions while managing company risk.
• Sense of humour is a plus.
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