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    Assistant Manager – Medical And Scientific Affairs

    Navitas Life Sciences
    10+ years
    Not Disclosed
    Bangalore
    10 Nov. 26, 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

    Here’s a concise summary of the Assistant Manager – Medical and Scientific Affairs role in Bangalore, India:

    Job Title: Assistant Manager – Medical and Scientific Affairs
    Location: Bangalore, India
    Job Type: Full-Time

    Job Overview:
    We are seeking an Assistant Manager – Medical and Scientific Affairs to join our growing team. This role will involve drafting and managing high-quality clinical documents, supporting regulatory submissions, and coordinating medical writing activities across departments. The ideal candidate will have significant experience in medical writing, with expertise in clinical and regulatory documentation.

    Key Responsibilities:

    • Regulatory Document Drafting:

      • Independently manage and draft clinical documents (e.g., Protocol, ICD, IB, IND, NDA, BLA, MAA, 505B2).
      • Prepare and review Non-clinical Overview (Module 2.4), Clinical Overview (Module 2.5), Module 2.6, Module 2.7, and briefing documents.

    • Study and Submission Support:

      • Contribute to the preparation of Pre-IND, Pre-NDA briefing packages, orphan drug designation feasibility reports, and expedited approval processes.
      • Support clinical trial-related documents, including SAP, Mock TLFs, eCRF outlines, and study-specific documents.

    • Project Management:

      • Coordinate medical writing activities within and across departments with minimal supervision.
      • Create accurate content for various deliverables, ensuring client expectations are met.

    • Collaboration & Compliance:

      • Ensure documentation compliance with internal and regulatory guidelines.
      • Work closely with cross-functional teams in data management, biostatistics, regulatory affairs, and medical leads.

    • Administrative Support:

      • Manage administrative requirements of the medical writing department.

    Qualifications:

    • Experience:
      • Minimum of 10+ years as a medical writer with significant experience in regulatory documents.
    • Education:
      • Medical/Pharmacy Graduate (PhD, MBBS, M.Pharm, Pharm D).
    • Skills:
      • Expertise in Word, PowerPoint, Excel, Adobe Acrobat for document preparation and editing.
      • In-depth knowledge of regulatory writing guidelines and the publication process.
      • Strong communication and interpersonal skills.
      • High fluency in English with a keen eye for detail and accuracy.
      • Ability to manage multiple tasks and prioritize effectively in a team-oriented environment.

    This is an excellent opportunity for an experienced Medical Writer to contribute to impactful regulatory submissions and collaborate with a dynamic team.

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