- 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.
- 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
- 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.
-
Manager & Counsel
hace 3 días
Amex Madrid, España**You Lead the Way. We've Got Your Back.**: · With the right backing, people and businesses have the power to progress in incredible ways. When you join Team Amex, you become part of a global and diverse community of colleagues with an unwavering commitment to back our customers, ...
-
Legal Internship
hace 1 semana
Abbott Laboratories Madrid, España PrácticasSHIP**About Abbott** · Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. · **W**orking at Abbott** · At Abbott, you can do work that matters ...
-
Associate Division Counsel
hace 6 días
Hexagon Asset Lifecycle Intelligence Madrid, España**Responsibilities**: · **Hexagon's Asset Lifecycle Intelligence division**(Hexagon) is seeking an Associate Division Counsel. · The Associate Division Counsel will support the Regional Division Counsel, who has the responsibility for all legal matters in the following regions: F ...
-
Senior Counsel, Employment
hace 6 días
Hewlett Packard EspañaAs Senior Counsel, Employment - Europe, UK&I, you will be a member of HP's worldwide Employment and Benefits Law Team. · This role will be responsible for assisting the Human Resources department and managers in the management and handling of all strategic labor and employment, e ...
-
Head of Dispute Management, Litigations and Risk
hace 6 días
Engage ESM Madrid, España**Publication Date**:Mar 31, 2023**Ref. No**:471934**Location**:BEZONS, FRANCE, FR, 95870 · - Bruxelles, BE, 1050 · - Amstelveen, NL, 1185 MC · - Budapest, HU, 1138 · - Madrid, M, ES, 28037**The future is our choice** · At Atos, as the global leader in secure and decarbonized dig ...
-
Legal Counsel
hace 3 días
The Green Recruitment Company Madrid, EspañaPosted 17 April 2023 · Salary Competitive Salary (DOE) · LocationMadrid · Job type Permanent · DisciplineRenewable Energy & Infrastructure · ReferenceGCLI-2APR23 · Contact NameGuillermo Camarasa · The Green Recruitment Company is searching for a Legal Counsel project to join a le ...
-
Associate Commercial Legal Counsel
hace 6 días
Talend Madrid, EspañaWHO WE ARE: · Talend, a leader in data integration and data governance, is changing the way the world makes decisions. In order to compete and win, IT and business leaders need data that they can trust and understand instantly. Talend Data Fabric is the only platform that seamles ...
-
Closing Manager
hace 6 días
Unison Infrastructure Madrid, EspañaUnison is a telecom and renewables infrastructure investment firm funded in partnership with Ardian - the global investment house based in Paris with over $150 billion in assets under management. Unison commenced operations in 2003 and today invests in real estate and infrastruct ...
-
Senior Counsel Privacy
hace 1 día
BAXTER Madrid, España**This is where you save and sustain lives** · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves ...
-
Technology Legal Counsel
hace 3 días
BANCO SANTANDER S.A. Madrid, EspañaTECHNOLOGY LEGAL COUNSEL - LYNX · Country: Spain · **Lynx Financial Crime Tech is looking for a LEGAL COUNSEL, based in our MADRID office.** · **WHY YOU SHOULD CONSIDER THIS OPPORTUNITY** · **Lynx Financial Crime Tech S.A **. We are an AI-driven software company specializing in d ...
-
Senior Legal Counsel Iberia
hace 4 horas
AXA Madrid, España**Senior Legal Counsel, Iberia** · Madrid, Spain · The Senior Legal Counsel will be dealing with day-to-day requests for legal advice coming from local management (esp. Country Management and Underwriting Teams) and from colleagues based abroad who are also interested in pursuing ...
-
Legal Counsel
hace 1 semana
Gaming Innovation Group Madrid, EspañaWe are looking for a responsible Legal Counsel to join our legal department in Ceuta, Madrid. · Key Tasks: · - Monitor regulatory and legal developments that impact our business and update our key management team; · - Maintain due diligence documents structured and up to date; · ...
-
Senior Legal Counsel Iberia
hace 1 día
XL Catlin Madrid, España**Flexible Work Eligible**: Flexible Work Schedule · **DISCOVER your opportunity** · **Senior Legal Counsel, Iberia** · Madrid, Spain · The Senior Legal Counsel will be dealing with day-to-day requests for legal advice coming from local management (esp. Country Management and Und ...
-
Legal Counsel Spain
hace 3 días
Goodman Madrid, EspañaMadrid or Barcelona · Always wanted to challenge the obvious and make great things happen? At Goodman we create space for your greatness. · Join our team in Spain based in our Madrid or Barcelona office as a Legal Counsel. As a Legal Counsel for Spain your primary objective is to ...
-
Senior Legal Counsel Gbf Cardiovascular, Metabolism
hace 4 horas
Merck KGaA Madrid, EspañaWork Your Magic with us · Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electro ...
-
Legal Counsel
hace 6 días
MULTIASISTENCIA S.A Madrid, España**LEGAL COUNSEL · **Necessary Features**: · Important innovative and global multinational, with more than 35 years of specialization in multi-risk claims management, located in the north of Madrid, seeks to incorporate a Corporate Legal Manager for its Madrid offices. · Having a ...
-
Legal Manager
hace 6 días
NextEnergy Group Madrid, España**THE ROLE** · With reference to the renewable energy sector (solar, on · - and off-shore wind, and battery energy storage systems for the time being) and the various geographies (at the moment, Italy, Greece, Romania and Canada) where Starlight is active, the Resource will be re ...
-
Corporate Counsel, Aws Energy, Aws Legal
hace 2 días
AWS EMEA SARL (Spain Branch) Madrid, España5+ years of post-qualification legal experience (PQE) with a focus on energy · - Licensed to practice law in the UK and/or US or other relevant EMEA jurisdiction. · - Ability to travel as needed · - Common sense, enthusiastic, great judgment, and a good sense of humor · As Corpor ...
-
Corporate Counsel, Emea Privacy
hace 1 día
Salesforce Madrid, EspañaJob Category · Global Affairs · Job Details · **_We're Salesforce inspiring the future of business with AI+ Data +CRM. Leading with our core values, we help companies across every industry blaze new trails and connect with customers in a whole new way. And, we empower you to be a ...
-
Senior Legal Counsel Neurology Spain
hace 1 semana
UCB S.A. Madrid, España**Make your mark for patients** · We are looking for a **Senior Legal Counsel **who is **analytic, team player and strategic thinker** to join us in our **Neurology Europe **team, based in our **Madrid**'s office in **Spain**. · **About the role** · As the Senior Legal Counsel yo ...
Urgente Managing Counsel - Madrid, España - Syneos Health
Descripción
Urgente Managing Counsel - Legal Regulatory GCPDescriptionManaging 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
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:
Get to know Syneos HealthOver 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 #J-18808-Ljbffr