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    Associate Manager - Regulatory Solutions

    Indegene
    2+ years
    Not Disclosed
    Bangalore
    10 Oct. 14, 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

    Senior Medical Writer

    Education:
    MBBS/PhD/MDS/BDS/MPharm/PharmD

    Experience:
    10 to 12 years of experience in writing clinical and regulatory documents supporting global filings (CTD Module 2 and Module 5).

    Role Purpose:
    This role is responsible for managing complex medical writing projects and providing review support for medical writing deliverables that contribute to the clinical regulatory writing portfolio, along with training junior writers.

    Skills:

    • Experience in authoring a wide range of clinical document types supporting regulatory filings, with a preference for Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, informed consent forms (ICFs), and investigator brochures (IBs).
    • Demonstrated excellence in focused writing and editing, adhering to defined processes and templates.
    • Ability to lead cross-functional teams in drafting scientific and medical content that addresses data interpretation, product claims, and internal/external inquiries.
    • Strong understanding of the clinical development process from program planning to submission, including clinical trial design.
    • Excellent communication skills suitable for a professional environment.
    • Effective time management, organizational, and interpersonal skills.
    • People management experience of over 2 years.
    • Customer-focused approach.
    • Comfort in following structured processes and templates for document delivery.
    • Ability to work independently while maintaining communication with the Sponsor’s medical writing project manager.
    • Flexibility to support various therapeutic areas to ensure business continuity.
    • Competence in developing, coordinating, and overseeing work plans for individual and multiple-document deliveries, ensuring efficient team operations and timely completion of all milestones.
    • Ability to manage tasks, roles, responsibilities, and timelines for the authoring team and reviewers.
    • Adherence to processes and sponsor-defined best practices.
    • Facilitation of review meetings, addressing feedback, and negotiating solutions.

    Knowledge Requirements:

    Scientific Knowledge:

    • Strong knowledge of regulatory guidelines/requirements, including those from the European Union and the United States.
    • Ability to interpret data and apply scientific knowledge to regulatory document writing (e.g., IB, protocols, amendments, CSR, clinical summaries).
    • Skill in building clinical or regulatory arguments in the absence of direct data using logic, analogy, and therapeutic area science.
    • Understanding of medical practices related to procedures, medications, and treatments for various disease states.
    • Consistency in messaging aligned with historical information and agreed strategies.
    • Capability to provide insights, alternatives, and suggestions based on previous experiences.
    • Experience writing protocols, amendments, CSRs, and CTD summary documents.

    Technology Skills:

    • Expert in MS Word, with a deep understanding of its functionalities.
    • Experience working with document management systems and managing workflows for eApproval/signatures.
    • Familiarity with Word add-ins that facilitate font, style, and reference management.
    • Flexibility to adapt to new tools and technologies.
    • Ability to train writers/authors on templates, guidelines, and tools.

    Responsibilities:

    • Prepare and review clinical study reports, protocols, investigator brochures, and submission documents (Module 2 summaries) without guidance from senior staff.
    • Apply lean authoring principles and structured content management during document development.
    • Coordinate activities for document review, consensus meetings, quality control, and finalization under tight timelines.
    • Develop and maintain project plans and work plans for team members.
    • Manage people effectively and work as an active member of cross-functional teams representing medical writing.
    • Conduct document kick-off meetings with writers and cross-functional representatives.
    • Ensure adherence to standard content and messaging across team members.
    • Maintain open communication and disseminate information appropriately among team members.
    • Assist in the orientation and coaching of junior team members as needed.
    • Conduct literature searches and screenings as required.
    • Participate in medical writing department initiatives and remain current with regulatory requirements.
    • Share lessons learned and best practices.
    • Ensure compliance with company training and time reporting.

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