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Job Description

With the support of a supervisor, the aRSL is accountable for overall management and coordination of the submission activities across EEA countries for assigned Clinical Trials (LSD Phase 1 - Phase 4) in GCTO EU under the leadership of the the Regional Submission Lead Head (RSL Head) or the Regional Submission Lead Manager (RSL Manager). The person will be accountable for the execution of the regional Clinical Trials Application (CTA)submission strategy, as well as the quality and completeness of the CTA regulatory submissions, throughout the lifecycle of the trial, facilitate the CTA submission in compliance with ICH/GCP, EU Clinical Trials Regulation (EU CTR) and country regulations and policies procedures.
 
Responsibilities include, but are not limited to:
• Coordinating and executing CTA submissions though CTIS portal, for assigned protocol across EEA countries in collaboration with all stakeholders
• Prepare submission strategy decisions for new trials and substantial modification with support of supervisor/ or EU-RSL Head
• Provide support for Drug Release Process for EEA countries
• Propose effective solutions for submission related issues during life cycle of study
• Works independently to achieve team goals
• Manage internal company systems and ensure compliance as per agreed regulatory requirements
• Timely execution of submissions across EEA countries, delivered with high quality
• Accountable for performance metrics within role accountabilities
• Subject Matter Expert for selected topics looking for efficiency and process improvements
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and function
 
Core competencies: 
• Expert on EU CTR (Clinical Trials Regulation)
• Project management skills
• Strong coordination and organizational skills
• Understanding of Drug Development, Clinical Trial Authorization Applications, and Applicable Regulations
• Scientific and clinical research knowledge and experience
• Understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously
• Ability to collaborate with different stakeholders within Global Clinical Trial and Research Labs in a matrix organization
• Communication skills requiring proficiency in written and spoken English. The incumbent must be competent in written and verbal communication. Some experience in leading discussions in an assertive and effective way with different stakeholders
• Ability to make decisions independently with oversight by supervisor
• Understanding of international cultural diversity in remote and virtual environment
• Expertise of core clinical systems, tools and metrics
• Ability to proactively develop risk management and mitigation plans in the assigned projects
 
Behavioral Competency Expectations: 
• Leadership skills that enable and drive alignment with the goals, purpose, and mission of the different business units
• Ability to identify problems, conflicts, and opportunities early and with the manager support, lead, analyze and prepare mitigation plans and drive conflict resolution
• Required to negotiate skillfully in tough situations with both internal and external group with the manager support if needed
• Open and growth mindset
• High emotional intelligence
• Able to work independently, with occasional guidance 
 
Experience Requirements: 
• Required: 5 years of relevant experience in Clinical Research
• Preferred including: several years of experience in regulatory submission experience in the European Union

Educational Requirements:
• Bachelor's Degree in Science (or comparable)

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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. 

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