Job Description

Position Overview & Responsibilities

Regional Regulatory Operations \xe2\x80\x93 Asia Pacific (RRO-AP)

RRO-AP\'s mission is to provide regional operational expertise to deliver high-quality, timely regulatory submissions for our products and contribute to the development, implementation, and support of innovative enabling processes and tools.

In delivering our mission, RRO-AP focuses on innovative business approaches and leverages state-of-the-art Regulatory Information Management (RIM) tools to drive process efficiency. The team possess diverse skill sets and work with global, regional, and local stakeholders to continuously optimize our operations.

\xe2\x80\x8bRRO-AP consists of 3 areas of expertise: Planning, Publishing and System Process and Regulatory Innovation (SPRI).

Brief Description of Position

The internship position in RRO-AP will support Publishing and SPRI activities. At the completion of this internship, the intern will gain an understanding of regulatory dossier publishing process and the related international standards, as well as working knowledge of selected Regulatory Information Management (RIM) tools.

Key Responsibilities:

Submission Publishing (60%)

The intern will support RRO-AP Regional Publishers in the following activities based on assignment:

• Perform publishing activities of dossiers which will be delivered to countries within Asia Pacific for Health Authority submission.
• Support maintenance of related execution processes in accordance with regional/country requirements for electronic submissions.

SPRI (30%)

The intern will support RRO-AP SPRI team in the following activities for the company\xe2\x80\x99s Health Registration Management System and Content Management System based on assignment:

• Support and facilitate Change Request Forms involving regulatory activities and data quality initiatives for the company\xe2\x80\x99s Health Registration Management System.
• Assist in the preparation of regional Community of Practice (CoP) sessions set up to collect feedback and respond to end users\xe2\x80\x99 queries on Health Registration Management System
• Support document template management, access request and document security requests in the company\xe2\x80\x99s Content Management System

Others (10%)

Support other tasks including but not limited to KPI/Metrics Reporting for the team, maintenance of submission planning templates for countries within Asia Pacific and developing improvement ideas to enhance operational efficiencies.

Job Requirements:

• Currently pursuing a Diploma or Undergraduate student majoring in Pharmacy, Life Science or equivalent with an interest in Regulatory Affairs
• Demonstrate proficiency with PowerPoint, Word, Excel, and other Office365 products and should be sufficiently IT savvy to learn new systems
• An excellent team player who is able to readily take on responsibilities and work independently
• Excellent verbal, written communication and documentation skills
• Have a positive, proactive, can-do attitude and a keen learner

Current Employees apply

Current Contingent Workers apply

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: Intern/Co-op (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

MSD