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    Regulatory Affairs Associate

    Parexel
    2-4 years
    Not Disclosed
    Remote
    10 Sept. 27, 2024
    Job Description
    Job Type: Remote 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 Overview

    Key Accountabilities:

    Project Execution:

    • Collaborate effectively within a team environment.
    • Operate within broad project guidelines as directed by the Project Lead or Technical Subject Matter Expert (SME).
    • With guidance from the Technical SME, prioritize tasks to achieve specific project outcomes.
    • Seek feedback from the Project Lead and colleagues to enhance personal performance.
    • Utilize information provided by senior colleagues to complete assigned project tasks.
    • Deliver high-quality work that meets the expectations of both the project lead and the client.
    • May serve as Project Lead for smaller projects or Work Stream Lead on larger initiatives, with clear guidance and support from the Line Manager.
    • Oversee project planning and setup, frequently interacting with the assigned Project Specialist (PS) or Project Manager (PM) to ensure effective project control (e.g., setup, forecasting, financial entries, invoicing).
    • Act as the primary client contact, ensuring accurate project reporting.
    • Ensure the project team meets client expectations for quality and timeliness.
    • Implement risk identification and issue escalation procedures.
    • Ensure project team compliance with required training.
    • Manage project financials, including accurate revenue forecasting.
    • Ensure the project team adheres to the scope of the contract.
    • Identify new opportunities for change in scope or additional business from existing work.
    • Complete timely project close-out activities.

    Consulting Activities and Relationship Management:

    • Follow and implement the organization's consulting models and methodologies under the guidance of the Project Lead and/or Technical SME.
    • Provide a limited range of consulting services within your area of expertise, under supervision.
    • Complete assigned tasks within project scope and objectives.
    • Identify project and internal issues to senior colleagues and the Project Lead/Technical SME.
    • Maintain professional interactions at all levels within the client organization and PAREXEL.
    • Identify project or client needs and communicate them to the Project Lead and/or Technical SME.
    • Foster client satisfaction through effective service delivery.

    Business Development:

    • Begin networking within the industry to maintain contacts and relationships with clients after engagements are complete.
    • Communicate potential new business leads to PC management and account managers.

    PAREXEL-related Activities:

    • Meet established metrics specified in the annual scorecard.
    • Complete basic job responsibilities, including timesheets, expense reports, CV maintenance, training compliance, project deliverable archiving, and participation in internal initiatives/projects.
    • Define self-development activities with management support to stay current in the industry.

    Skills:

    • Knowledge of project management principles.
    • Client-focused approach.
    • Results-oriented mindset.
    • Strong teamwork and collaboration skills.
    • Consulting capabilities.
    • Excellent interpersonal and intercultural communication skills, both written and verbal.
    • Critical thinking and problem-solving abilities.
    • Proficiency in the local language and extensive working knowledge of English.

    Knowledge and Experience:

    • 2-4 years of experience in an industry-related environment.

    Education:

    • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline.

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