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Medical Operation Manager

3+ years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Operations Manager

Updated: Yesterday
Location: India (Mumbai Preferred) - Client-Based
Job ID: 24005475


Position Overview

Syneos Health® is a global leader in biopharmaceutical solutions, committed to accelerating customer success through integrated insights in clinical, medical affairs, and commercial areas. Our Clinical Development model puts the customer and the patient at the heart of everything we do, as we continuously aim to simplify processes and drive innovative solutions.

WORK HERE MATTERS EVERYWHERE.


Why Join Syneos Health?

  • Career Development: We offer growth through career progression, skill development, and an active Total Rewards program.
  • Inclusive Culture: Our Total Self culture fosters an environment where all employees can be authentic, enabling diverse perspectives to thrive.
  • Employee Wellbeing: We prioritize the welfare of our employees through support programs and inclusive workplace policies.

Key Responsibilities

  1. Medical Governance and Operations

    • Support the implementation of medical governance and standard operating procedures (SOPs) across the affiliate.
    • Manage and coordinate medical governance projects within India.
  2. Medical Approvals and Compliance

    • Collaborate with the medical team to review and oversee approvals in the TRIMM system for interactions with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs), and Master Service Agreements (MSAs), ensuring regulatory compliance.
    • Conduct comprehensive TRIMM platform analysis to ensure adherence to audit recommendations and compliance standards.
  3. Documentation and Archival Management

    • Play a critical role in reviewing and archiving documents related to events within the TRIMM system for future compliance audits.
  4. Collaboration with TRIMM ITS Team

    • Work closely with the TRIMM Information Technology Services (ITS) team to provide feedback and contribute to system improvements and process enhancements.
  5. Grant Request Forms (GRFs) Management

    • Review and ensure the accuracy and compliance of Grant Request Forms (GRFs) with internal and external regulations.
  6. Cross-Functional Communication

    • Serve as a liaison across departments such as Sales, Marketing, and Live Monitoring teams to ensure effective collaboration and alignment of objectives.

Qualifications

  • Education: Minimum Bachelor's degree.
  • Experience:
    • A minimum of 3 years of experience in the pharmaceutical industry, preferably in a medical affairs role.
  • Location Preference: Mumbai, India.
  • Additional Information:
    • Minimal travel (up to 25%) may be required.

Why Syneos Health is a Great Choice

Over the last five years, Syneos Health has been involved in 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, working across 73,000 sites and with 675,000+ trial patients globally.


Additional Information

The job responsibilities outlined here may evolve as the company seeks to stay agile in a competitive and ever-changing environment. Syneos Health is committed to diversity and equality, complying with all local legislation, and providing reasonable accommodations to employees as needed.


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