Principal Legal Contracts Management - Home Based EMEA

Description

Principal Legal Contracts Management - Home Based EMEA

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.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

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

• Establishes, maintains and updates training material for BU on various aspects of site contracting process from country requirements, sponsor processes to other subject matter areas that affect site contracting process.
• Develops and shares expertise regarding sponsor processes, local country/site investigator contracts requirements within the team and BU.
• Serve as mentor to less experienced members of the team.
• Actively participates in higher level discussions about overall company goals, functional objectives in the BU, and specific project aims.
• Subject matter expert equipped to help resolve global site contracting and legal issues arising from clinical trial set up activities.
• Develop and maintain of Company’s suite of investigator contract templates, confidentiality agreements, letter of authorization and improve associated processes and procedures around this documentation.
• Proposes contracting solutions to issues that may arise during a project or contract life cycle, to enhance negotiation strategy and ensure deliverables are met.
• Establishes site contract project strategies around language parameters to reflect sponsor's master service agreement terms and required processes.
• Identifies possible contract or process operational riskand proactively works to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.
• Serves as a resource to business development and represents site contracts at internal or customer meetings and input as required into site contracting RFPs, as required.
• Ensures site contract templates are drafted taking into consideration key operational aspects indicated in the relevant operational documents (e.g. protocol, pre-study visit report, etc.), as well as in the customer agreement documents at a project and organizational level.
• Establishes strong working relationships and collaboration with Sponsor to ensure site contract templates fit into the global strategy set for the program.
• Responsible for drafting, negotiating with Sponsor legal department or contract representatives and harmonizing site contract templates, site contract language, fallback templates and parameters, within Company processes and works closely with Company’s corporate Legal and other internal stakeholders to obtain any cross-functional input needed. Identifies risk areas for Company arising form site contracts and offer mitigation solutions to protect Company.
• Serves as main point of contact for the sponsor legal to legal escalations to obtain timely approval of changes outside of approved negotiation and provide solutions to broker execution of contract-related documents for a given study,
• Generates site contract documents of all variations, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Supports existing Company initiatives to streamline site contract negotiations. Introduce new initiatives to facilitate better contract negotiations and solutions and lead working groups to develop and improve aspects of sitecontracting strategy, policy or documentation.
• Creates and maintains document status reports and updates department team members on a regular basis; ensures appropriate documentation is maintained for all exceptions.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Represents the Company at professional meetings or seminars.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
  
  

Qualifications

• BS degree in life sciences and/or English, or equivalent combination of education and experience. Legal degree or equivalent required.
• Extensive experience in a CRO and related contract management, legal and/or site start-up experience.
• Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. Strong presentation, documentation, and interpersonal skills.
• Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, outlook, and Internet.
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
• Strong leadership skills, ability to teach/mentor team members. Ability to coach employees to reach performance objectives. Strong background in issue resolution, meeting customer deliverables and driving best practices at organization or customer portfolio level
  
  

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.

http://www.syneoshealth.com

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.