Specialist

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 MRLGCTO ETJOBS MSJR NOTICE FOR INTERNAL APPLICANTS 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. Residents of Colorado Click here to request this role's pay range. 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. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 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