Specialist, Clinical Outcome Assessment (COA) - licensing and translations agreements (Hybrid)

Job Description
GCTO is a global organization operating in over 50 countries and is responsible in the delivery of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. The Regional organization is comprised of 4 distinct regions (North America, Latin America, Asia Pacific, and Europe) and is responsible for a significant proportion of the GCTO budget, staff and deliverables.
Global Site Agreements (GSA) is a company Research Laboratories organization that drafts, negotiates, and executes agreements on a global basis. We are responsible for negotiating industry sponsored clinical trial agreements, confidentiality agreements, and other type of agreements related to clinical research.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
As a GSA Specialist you will work closely with experienced GSA team to:

• Review Clinical Outcome Assessment (COA) licensing and translations agreements for both in house and outsourced trials; and provide support in- drafting, negotiating, and executing such agreements.
• Act as liaison to our company's Office of General Counsel, Privacy, Compliance and Clinical Teams, as appropriate, to resolve contractual/legal issues with copyright holders/authors and developers.
• Build and maintain relationships with instrument authors, copyright holders and distributors, and translation vendors.
• Support implementation of COA measures in connection with our company clinical trials through strong project management and timely delivery of COA licensing and translation deliverables.
• Maintain high level of collaboration and interaction with the GCTO Country Operations/Research Division Functional area and act as a liaison with Global Operations.
• Participate in regional and global improvement projects, identify and propose improvements to the internal systems or processes to ensure high compliance and efficiency standards.
• Support appropriate GCTO region/Research Division functional area meetings and trainings to ensure understanding of contracting process.
• Support departmental initiatives including filing, metric reporting and quality control.

Qualifications
Education:

• Bachelor's Degree with a minimum of 2 years of relevant experience in the pharmaceutical industry or an Associate's Degree with a minimum of 5 years of relevant experience in the pharmaceutical industry

Required:

• Superior communication, presentation and writing skills.
• Excellent analytical ability
• Good team player and ability to work independently in a global setting.
• Microsoft Office and data analytics proficiency

Preferred:

• Prior work experience in clinical outcome assessment licensing and translations agreement negotiation
• Project management experience and/or certification
• Good Clinical Practice certification/training

#EligibleforERP
MRLGCTO
ETJOBS
MSJR
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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
05/22/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:05/22/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R289402