.Updated: March 8, 2024Location: Portugal-Europe PRT-Home-Based, PortugalJob ID:24001766-PRT975Managing CounselSyneos 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 EVERYWHEREWhy 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
