ICON Clinical Research
ICON Clinical Research San Juan Puerto Rico
2 months ago
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world...
The Senior Specialist, System Process & Regulatory Innovation (SPRI) will support regional activities associated with the implementation and support of Global Regulatory Affairs, Compliance and Safety (GRACS) Digital Strategy projects and systems. With some understanding of regulatory affairs and supporting business processes, this role provides support across a portfolio of systems and their related capabilities including but not limited to the following:
content management for regulatory submissions; submission planning & execution; health registration & regulatory information management systems. This role partners with Innovation & Information Management (IIM), Business System Owners (BSOs) and key regional stakeholders to ensure the successful regional implementation of GRACS Regulatory systems and to support continuous enhancements of capabilities and processes.
The Regional SPRI will support all countries in the region for assigned capabilities and will represent regional needs for system and process changes in global project activities. They are responsible for understanding the underlying business processes that the systems support and where necessary, work with Business Process Owners (BPOs) to adapt those procedures to align with regional needs/ country-specific requirements. In this role they will be the primary contact for the regional users with regards to questions on system usage, existing process, and subsequent process improvement initiatives, and will provide additional user training if required. They will be responsible for evaluation of regional data and creating / implementing action plans for the region to address data quality issues. They will also ensure that tasks within the global project that require regional input are successfully completed.
The Regional SPRI may also be involved in regional projects that support the local business and regulatory strategy where their skillset and experience in leading and working in teams, change management and business process development can be used, especially on projects with a linkage between technology enablement of business processes including automation opportunities.
They may also provide support or information across other projects and systems on an as needed basis and may take on roles and tasks as part of a global implementation project team for a specific project.
Primary Activities include but are not limited to:
• Work with colleagues from Regulatory Affairs International (RAI), International Chemistry and Manufacturing Control (iCMC), Innovation Quality and Strategic Execution (IQSE) and other GRACS functions to deliver on regional objectives.
• Understand the regional needs and changes in the external environment, ensuring that these are accounted for in the GRACS Digital Strategy and departmental priorities as applicable (e.g., RAI, CMC (Chemistry, Manufacturing and Control), Safety, etc.). Participate in the development of communications and change management initiatives associated with GRACS Digital Strategy projects.
• Participate in / organize the Regional Communication forums to enable dissemination of knowledge on business processes and system changes that impact GRACS IIM Systems
• Represent the needs of the Region in different Change Control Boards for their assigned systems to ensure that changes are appropriate for the region.
• Provide direct support to system users in any region to correctly enter data into GRACS Systems, for low-frequency, high-complexity system interactions and/or explore automation-based solutions.
• Assist in developing and facilitating global regulatory training when new business processes are rolled out or new functionalities are implemented. Provide additional refresher training, as needed.
• Provide strong, cross-functional team leadership within the region and report on progress on delivery of regional objectives to Regional Management, Project Team Leads and other Senior Managers as required.
• Collaborate with other Regional SPRI staff to align activities, share best practices, and ensure the efficient completion of future projects.
Qualifications, Skills & Experience
• Bachelor’s degree in a science, information technology or Pharmacy discipline required.
• Advanced degree preferred (engineering or scientific discipline, MBA (master's in business administration)).
• Min of 4-6 years’ experience in Regulatory Affairs, or Regulatory Operations, and/ or pharmaceutical manufacturing with at least 3 years’ experience in implementing and/or supporting regulatory information systems
• Ability to lead and influence others with broad organizational awareness and knowledge of touch points/interdependencies s
• Ability to prioritize their own work across several ongoing projects
• Demonstrate problem solving skills within organizations and teams with experience analysing information and developing actions to improve data quality and process or system improvements
• Experience in project management methodologies
• Experience with change management, developing training materials and communication strategies
• Fluent in English and Spanish. Portuguese is desired.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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
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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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Residents of Colorado:
Click here to request this role’s pay range.
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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.
Flexible Work Arrangements:
Hybrid, Remote Work
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San Juan Puerto Rico
Director, Regulatory Affairs San Juan jobs
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