Associate Specialist, Global Submissions Publishing

Job description

Job Description

Position Title Associate Specialist, Global Submissions Publishing (GSP) Department Regulatory Planning and Publishing (RPP) Brief Description of Position Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions.

Submission Publishing is responsible for assembling, linking, and delivering high-quality regulatory dossiers to health authorities, facilitating expeditious agency reviews that align with industry cycle times.

Key Responsibilities of Submission Publishing

Submission Activities Support : Execute the comprehensive publishing process, including quality control, verification, finalization, delivery of submission dossiers, and archiving to ensure compliance with industry standards and regulatory requirements.

Timely Completion of Submission Assemblies

Ensure that all dossiers are finalized and submitted by the specified deadlines to uphold project schedules and achieve organizational objectives.

Shared Responsibilities

Collaboration : Collaborate with authors, contributors, and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success.

Testing and Implementation of New Tools and Processes

Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness.

Development of Administrative Documentation

Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines, and training materials to support publishing processes.

Continuous Learning and Development

Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences. Qualifications, Skills & Experience Education Minimum Requirement: High School Diploma or equivalent (no relative experience)

Required Skills and Experience

Interpersonal Skills : Ability to work collaboratively with others and communicate effectively, both verbally and in writing.

Technical Proficiency

Knowledge of computer programs such as MS Word and Adobe Acrobat Professional, with a demonstrated ability to learn new systems and technologies quickly.

Time Management

Strong organizational skills to manage multiple time-sensitive assignments efficiently.

Adaptability

Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures.

Cultural Sensitivity

Good interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages.

Quality and Compliance Awareness

Demonstrates an understanding of the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables.

Problem Solving and Critical Thinkings

Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges.

Additional location(s) Compensation Information

Required Skills: Adverse Event Report, Adverse Event Report, Audits Compliance, Change Management, Competency Management, Conceptual Thinking, Continuous Development, Data Quality Assurance, Documentation Maintenance, Documentation Preparation, Document Control Systems, Document Management, Efficiency Improvements, Electronic Common Technical Document (eCTD), Employee Training Programs, Lateral Thinking, Microsoft Word, Multitasking, Performance Improvements, Policy Implementation, Process Improvements, Product Delivery, Records Retention Management, Regulatory Applications, Regulatory Communications {+ 7 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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: 10/22/2026 *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.