Associate Regional Submission Lead

Job Description

JD R336750 Associate Regional Submission Lead

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.

We are looking for an Associate Regional Submission Lead to join our team. 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 Submision 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 Our Company’s policies procedures.

Responsibilities include, but are not limited to:

• Coordinating and executing CTA submissions though CTIS portal, for assigned protocols 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
• 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 GCTO and our Research & Development Division 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 Our Company Research Labs (our Research & Development Division), Global Clinical Development (GCD) and GCTO
• 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: 2 years’ experience in regulatory submission experience in the European Union

Educational Requirements:

• Bachelor's Degree in Science (or comparable)

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/5/2025

*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: R336750