Makrocare is hiring talented life sciences and clinical research professionals for multiple opportunities in Hyderabad, Telangana. The company is currently recruiting for Research Analyst-I (Regulatory Bodies – Secondary Research), Clinical Quality Assurance (CQA) – Associate, and Clinical Analyst positions.

These Makrocare jobs are suitable for candidates with experience in secondary research, regulatory affairs, clinical quality assurance, clinical research, ICH-GCP, QMS, EDC, and clinical systems. Candidates with relevant qualifications and experience are encouraged to apply.

Available Positions at Makrocare

1. Research Analyst – I (Regulatory Bodies – Secondary Research)

Experience: 1–3 Years
Location: Hyderabad
Qualification: Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmacy, or a related field

Role Overview

The Research Analyst-I will conduct secondary research and regulatory intelligence activities related to drugs, medical devices, clinical trials, and product development. The role involves collecting, evaluating, organizing, and analyzing scientific, legal, and regulatory information from multiple public sources.

Key Responsibilities

• Conduct comprehensive secondary research on drugs, medical devices, and clinical products.
• Develop detailed product profiles and regulatory intelligence reports.
• Collect and analyze information using modern and traditional research methods.
• Review scientific, legal, and regulatory documents.
• Gather information from public reports, filings, clinical trial databases, and company publications.
• Monitor changes in regulatory legislation and guidelines.
• Analyze clinical trial and scientific data to support drug development.
• Review regulatory requirements related to labeling, storage, and packaging.
• Conduct intelligence research on pharmaceutical, biotechnology, academic, and public organizations.
• Capture and update information from press releases, SEC filings, clinical trial reports, and scientific publications.

Required Skills

• Secondary Research
• Regulatory Affairs
• Regulatory Intelligence
• Document Analysis
• Data Analysis
• Clinical Trials
• Drug Development
• Regulatory Compliance
• Information Management
• Scientific Research

2. Clinical Quality Assurance (CQA) – Associate

Experience: 2–3 Years
Location: Hyderabad / Madhapur, Telangana
Qualification: Bachelor’s or Master’s degree in Life Sciences or a related field

Role Overview

The Clinical Quality Assurance Associate will support the Quality Assurance function by maintaining quality systems, reviewing SOPs, conducting internal audits, managing CQA documentation, and ensuring compliance with applicable regulations and ICH-GCP guidelines.

Key Responsibilities

• Maintain, review, and approve Standard Operating Procedures (SOPs).
• Ensure compliance with ISO standards and applicable regulations.
• Prepare and review Quality Management System (QMS) documents.
• Manage SOPs and training records through the learning management system.
• Maintain the Clinical Quality Assurance document repository.
• Archive validation protocols and regulatory documents.
• Conduct internal audits of clinical research activities.
• Ensure compliance with ICH-GCP and company procedures.
• Provide training on ISO standards and applicable regulations.
• Manage change controls, deviations, CAPAs, amendments, and Notes to File.
• Maintain relevant quality logs and documentation.
• Support annual CQA reporting and trend analysis.
• Assist during client, certification body, and regulatory authority audits.

Required Skills

• Clinical Quality Assurance
• CQA
• Quality Management System (QMS)
• ICH-GCP
• ISO Standards
• SOP Management
• Internal Audit
• External Audit
• CAPA
• Change Control
• Deviation Management
• Clinical Research

3. Clinical Analyst

Experience: 2–4 Years
Location: Hyderabad / Madhapur, Telangana

Role Overview

The Clinical Analyst will support clinical research and clinical supplies projects, particularly from a functional and software perspective. The role involves translating business and study requirements into functional specifications and supporting the review and testing of clinical systems.

Key Responsibilities

• Review and analyze clinical project and study requirements.
• Define and document functional requirements.
• Map business requirements into specifications and related documents.
• Prepare user acceptance plans and test plans.
• Propose clinical solutions to software development teams.
• Participate in pre-project documentation activities.
• Review and test clinical systems as a subject matter expert.
• Develop testing scenarios and impact assessments for system changes.
• Create workflow diagrams and process documentation.
• Support clinical studies and clinical supplies projects.
• Work with MedDRA, ICH-GCP, GCP, SOPs, and EDC systems.

Required Skills

• Clinical Research
• Clinical Analysis
• Clinical Systems
• MedDRA
• ICH-GCP
• Good Clinical Practice (GCP)
• Electronic Data Capture (EDC)
• SOPs
• Functional Requirements
• User Acceptance Testing
• Test Planning
• Software Development

Qualifications and Eligibility

Candidates applying for these Makrocare clinical research jobs should have relevant educational qualifications and experience based on the position.

Preferred Educational Background

• B.Pharm / M.Pharm
• Pharm.D
• B.Sc / M.Sc Life Sciences
• Biotechnology
• Clinical Research
• Other relevant Life Sciences disciplines

Experience Requirements

Why Consider Makrocare?

These opportunities provide exposure to important areas of the pharmaceutical and clinical research industry, including:

• Regulatory Affairs and Regulatory Intelligence
• Secondary Research
• Clinical Quality Assurance
• Quality Management Systems
• Clinical Trials
• Clinical Data and Systems
• Drug Development
• Regulatory Compliance
• Clinical Research Operations

Professionals working in these roles can gain experience across regulatory, quality, research, and clinical technology functions.

How to Apply

Application Link For Research Analyst-I (Regulatory Bodies – Secondary Research)

Application Link For Clinical Quality Assurance Associate

Application Link For Clinical Analyst