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    Medical Affairs Specialist

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    2+ years
    Not Disclosed
    India
    10 Oct. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Job Title: Medical Affairs Specialist - Chennai/Trivandrum, India (Office or Home Based)

    Company: ICON plc

    About Us: ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development!

    Position Overview: As a Medical Affairs Specialist, you will provide support to Medical Affairs management and Medical Monitors in all aspects of Medical Affairs activities. Your role will include offering medical and scientific consultation to internal and external customers while ensuring compliance with ICON standards and other applicable regulations.

    Key Responsibilities:

    • Adhere to ICON's values, emphasizing our commitment to People, Clients, and Performance.
    • Embrace and contribute to a culture of process improvement to enhance business value and meet client needs.
    • Travel as required (less than 10%) for domestic and/or international engagements.
    • Serve as an integral part of the Medical Affairs team.
    • Demonstrate knowledge of assigned protocols with oversight from the Medical Monitor.
    • Author and contribute to core Medical Affairs deliverables (MMPs, trackers, reports) as contracted.
    • Provide functional oversight for Medical Affairs activities as directed by the lead Medical Monitor for specific studies.
    • Identify potential issues relevant to Medical Affairs project tasks and escalate as necessary.
    • Review and maintain accuracy in Medical Affairs tracking systems and project files.
    • Perform reviews of clinical and diagnostic data related to patient safety under the guidance of the Medical Monitor.
    • Liaise with investigational sites and sponsors regarding Medical Affairs issues with oversight from the Medical Monitor.
    • Participate in internal and external project team meetings and teleconferences as required.
    • Act as a resource for investigational sites and ICON personnel on safety-related issues with assistance from the Medical Monitor.
    • Collaborate with project managers and other departments as needed.
    • Assist the Medical Monitor with weekly and monthly project status reports.
    • Contribute to presentations for start-up meetings, Investigator meetings, and other requests.
    • Liaise with safety and regulatory teams for effective communication regarding SAEs and regulatory updates.
    • Assist with financial oversight of projects, including tracking metrics and Change Orders.
    • Review contracts and ensure alignment with Good Practice Training (GPT) alongside the Medical Monitor.
    • Coordinate periodic project review meetings.

    Qualifications:

    • Minimum of 2 years of relevant clinical research industry experience.
    • Degree in Health or a related field.
    • Basic knowledge of medical terminology and coding systems.
    • Proficient in advanced English (reading, writing, speaking).
    • Excellent written and verbal communication skills.
    • Advanced proficiency in Microsoft Office.
    • Desirable experience in the pharmaceutical industry and knowledge of ICH guidelines.

    Work Arrangement: This is a hybrid position: 2 days at home and 3 days in the office.

    What We Offer: At ICON, our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

    In addition to a competitive salary, ICON offers a range of benefits, including:

    • Various annual leave entitlements.
    • Health insurance options tailored to you and your family’s needs.
    • Competitive retirement planning offerings.
    • Access to the Global Employee Assistance Programme, providing 24-hour support from a network of over 80,000 professionals.
    • Life assurance and flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, etc.).

    To learn more about our benefits, visit our careers site.

    Diversity and Inclusion: At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. Our diverse workforce fosters innovation, allowing us to better serve our people, patients, customers, and communities. We are committed to providing an inclusive and accessible environment for all candidates. ICON is dedicated to a workplace free of discrimination and harassment, and all qualified applicants will receive equal consideration for employment.

    If you require reasonable accommodations due to a medical condition or disability during the application process, please let us know or submit a request here.

    Interested but Unsure? If you're interested in the role but don’t meet all requirements, we encourage you to apply. You might be exactly what we’re looking for!

    Current ICON Employees: If you are a current ICON employee, please click here to apply.

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