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    Prin Reg Affairs Assistant

    Thermo Fisher Scientific
    3+ years
    Not Disclosed
    Bangalore
    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: Regulatory Affairs Administrative Support
    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions: Office

    Job Description:

    At Thermo Fisher Scientific, you'll engage in meaningful work that creates a positive global impact. Join our team in fulfilling our mission to enable customers to make the world healthier, cleaner, and safer. We equip our teams with the resources needed to achieve their career goals while advancing scientific research, development, and delivery of transformative therapies. With clinical trials conducted in over 100 countries, our work through the PPD clinical research portfolio spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will enhance health outcomes for communities worldwide.

    Discover Impactful Work:
    As part of our Regulatory Affairs global team within PPD clinical research services, you will provide advanced administrative, contractual, and financial support, helping to deliver regulatory science services that accelerate innovation and improve regulatory decision-making.

    A Day in the Life:

    • Coordinate the timely collection and management of data, metrics, and experience statements for proposal and budget development in response to Request for Proposals (RFPs).
    • Support the preparation of bids and proposals; generate, track, and analyze data for proposals, revisions, contract modifications, and bid defenses.
    • Assist department management in reporting financial, contractual, and budget data.
    • Provide project-specific services, documentation, and coordination, supporting reporting to management and clients.
    • Serve as a team lead, training and reviewing the work of junior team members.

    Keys to Success:

    Education:

    • High school diploma or equivalent and relevant formal academic/vocational qualification.

    Experience:

    • At least 6 years of relevant experience. Preferably, 3+ years in bid preparation and/or the development and fulfillment of contracts and RFP requirements.

    Knowledge, Skills, and Abilities:

    • Excellent organizational and planning skills to manage shifting priorities effectively.
    • Strong understanding of contractual and proposal documents.
    • Ability to work effectively both on a team and independently with minimal supervision.
    • Exceptional electronic document production skills.
    • Proficient in Microsoft Office and other computer applications.
    • Exceptional attention to detail and quality of documentation.
    • Outstanding interpersonal skills, with the ability to interact effectively with customers.
    • Excellent verbal and written communication skills.
    • Capable of multitasking and working under pressure.
    • Strong analytical, business, and math skills.

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