Merck Sharp & Dohme Hiring for Global Submission Publishing, Clinical Research & Clinical Ops Manager

MSD (Merck Sharp & Dohme) is hiring for three full-time positions in India: Associate Specialist, Global Submissions Publishing; Senior Associate, Clinical Research; and Clinical Operations Manager. The openings are based in Hyderabad and Gurugram, Haryana. The Global Submissions Publishing position offers a remote work arrangement, while the other two positions are listed as not applicable for remote work arrangements.

Eligible candidates can apply through the official MSD careers portal before the respective application deadlines.

MSD Recruitment 2026: Job Details

1. Associate Specialist, Global Submissions Publishing

Location: Hyderabad, Telangana, India
Work Arrangement: Remote
Job Requisition ID: R419047
Application Deadline: October 22, 2026

Job Description

MSD is hiring an Associate Specialist for Global Submissions Publishing within its Regulatory Planning and Publishing department. The role supports the preparation, quality control, finalization, delivery, and archiving of regulatory submission dossiers in accordance with global regulatory requirements and internal guidelines.

Key Responsibilities

• Execute regulatory submission publishing activities, including quality control, verification, finalization, delivery, and archiving.
• Ensure submission dossiers are completed and submitted within specified timelines.
• Collaborate with authors, contributors, and other stakeholders to maintain submission quality.
• Participate in testing and evaluating new publishing tools and processes.
• Assist in preparing and maintaining standard operating procedures, guidelines, training materials, and other administrative documentation.
• Stay updated on regulatory publishing practices and relevant regulatory changes.

Eligibility and Qualifications

• Minimum educational requirement: High School Diploma or equivalent.
• The posting states that no relevant experience is required for the minimum education requirement.

Required Skills

• Microsoft Word and Adobe Acrobat Professional.
• Written and verbal communication.
• Time management and organizational skills.
• Ability to learn new systems and technologies.
• Quality assurance and regulatory compliance awareness.
• Problem-solving and critical-thinking abilities.
• Collaboration, adaptability, and cultural sensitivity.
• Knowledge of electronic Common Technical Document (eCTD), document management, regulatory applications, and records retention.

2. Senior Associate, Clinical Research

Location: Gurugram, Haryana, India – Vatika Towers
Work Arrangement: Not Applicable
Job Requisition ID: R420727
Application Deadline: October 22, 2026

Job Description

The Senior Associate, Clinical Research position supports clinical trial administration, essential document management, regulatory and site start-up activities, clinical trial agreements, budgeting, investigator payments, and meeting coordination.

The role involves working with country teams, investigators, financial representatives, and other stakeholders to support compliant clinical trial execution.

Key Responsibilities

• Track essential clinical trial documents and safety reports.
• Maintain clinical trial management systems (CTMS), databases, and study trackers.
• Coordinate clinical and non-clinical supplies and applicable labeling requirements.
• Prepare, distribute, and archive clinical documents, including electronic Trial Master File (eTMF) documentation.
• Assist with eTMF reconciliation and execute the eTMF Quality Control Plan.
• Support site evaluation, site start-up, regulatory submissions, and IRB/ERC submission packages.
• Obtain, track, and update study insurance certificates.
• Develop, update, and maintain country and site budgets, contracts, and Clinical Trial Research Agreements (CTRAs).
• Track contract negotiations and process investigator, vendor, and grant payments.
• Maintain financial and compliance documentation.
• Organize clinical research meetings and support local investigator meetings.

Required Skills

• Clinical research and clinical trial operations.
• Good Clinical Practice (GCP) and ICH-GCP guidelines.
• Clinical trial documentation and document management.
• Strong Microsoft Excel and Microsoft Office skills.
• Clinical trial management systems and other clinical IT applications.
• Regulatory submissions and drug regulatory affairs.
• Budget development, contract processing, and negotiation.
• Effective written and verbal communication in English and local languages.
• Time management, organizational skills, and conflict management.
• Ability to work independently, manage multiple tasks, and solve problems proactively.

3. Clinical Operations Manager

Location: Gurugram, Haryana, India – Vatika Towers
Work Arrangement: Not Applicable
Job Requisition ID: R420726
Application Deadline: October 22, 2026

Job Description

MSD is hiring a Clinical Operations Manager to oversee clinical trial performance, compliance, budgets, regulatory submissions, and site readiness for assigned country protocols. The role requires coordination with clinical research teams, investigators, vendors, regulatory authorities, finance, and legal departments.

Key Responsibilities

• Manage country and site budgets, including the development, negotiation, and completion of Clinical Trial Research Agreements (CTRAs).
• Oversee clinical research payments, payment reconciliation, and financial forecasting.
• Execute and oversee country-level clinical trial submissions and approvals.
• Coordinate local-language informed consent documents and translations.
• Manage protocol deliverables, timelines, and regulatory compliance.
• Coordinate with clinical research, finance, legal, and regulatory teams to meet study milestones.
• Oversee clinical supplies, import and export requirements, document filing, archiving, and retention.
• Manage local regulatory and financial compliance requirements.
• Support vendors, investigators, external partners, and clinical trial sites.
• Contribute to standard operating procedures, process improvements, training, and knowledge sharing.
• Identify risks, analyze root causes, and develop mitigation plans.

Eligibility and Qualifications

• Bachelor’s degree in Business, Finance, Administration, Life Sciences, or equivalent healthcare-related experience.
• At least 5 years of experience in clinical research or a combination of clinical research and finance/business experience.

Required Skills

• Clinical operations and clinical site management.
• Clinical trial planning, monitoring, and compliance.
• Clinical Trial Agreements (CTAs).
• Knowledge of ICH-GCP guidelines.
• Country-level regulatory submissions and approval processes.
• Budget management and contract negotiation.
• Financial and legal compliance.
• Risk management and problem-solving.
• Strong communication, leadership, negotiation, and influencing skills.
• Training, mentoring, and team coordination.
• Ability to manage multiple protocols and deliverables independently.

Quick Summary