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Assistant Manager – Medical And Scientific Affairs

10+ years
Preffered by Company
10 Aug. 29, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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 Description: Assistant Manager – Medical and Scientific Affairs

We are seeking an experienced Assistant Manager – Medical and Scientific Affairs to join our expanding team. In this role, you will be responsible for overseeing the creation and management of high-quality clinical and regulatory documents, ensuring they meet both internal and external standards.

Key Responsibilities:

  • Document Management:

    • Draft and manage high-quality clinical documents, including Protocols, Informed Consent Documents (ICD), Investigator Brochures (IB), diaries, and other regulatory submission materials (e.g., IND, NDA, BLA, MAA, 505(b)(2), Biosimilars, hybrid applications).
    • Prepare and review Non-clinical Overview (Module 2.4), Clinical Overview (Module 2.5), and Modules 2.6 and 2.7, as well as briefing documents.
    • Develop Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) text summaries.
  • Regulatory Documentation:

    • Draft Pre-IND, Pre-NDA briefing packages, Special Animal Model (SAM) briefing packages, orphan drug designation feasibility reports, and expedited approval process documents.
    • Review and support the preparation of clinical trial-related documents such as Statistical Analysis Plans (SAP), Mock Tables, Listings, and Figures (TLFs), electronic Case Report Form (eCRF) outlines, and other study-specific documents.
  • Project Coordination:

    • Manage medical writing activities for individual studies, coordinating with various departments with minimal supervision.
    • Create impactful and accurate content for diverse deliverables, aligning with client expectations through teamwork, deadline management, and scientific expertise.
  • Compliance and Communication:

    • Ensure all documentation complies with internal standards and external regulatory guidelines.
    • Interact with department heads and staff across data management, biostatistics, regulatory affairs, and medical leads to produce high-quality writing deliverables.
  • Administrative Oversight:

    • Oversee the administrative aspects of the medical writing department, ensuring smooth operation and effective management.

Desirable Skills and Experience:

  • Experience:

    • Minimum of 10+ years as a professional medical writer with substantial experience in regulatory medical writing.
    • Proven expertise in preparing and managing various regulatory documents.
  • Technical Skills:

    • Proficient in Microsoft Word, PowerPoint, Excel, and Adobe Acrobat, with advanced skills in PDF editing and presentation development.
    • Basic understanding of the publication process and congress activities.
  • Interpersonal Skills:

    • Excellent interpersonal and communication skills, capable of liaising effectively with internal teams, clients, Key Opinion Leaders (KOLs), and other stakeholders.
    • Strong attention to detail and accuracy, with a passion for writing and communicating scientific information to diverse audiences.
  • Personal Attributes:

    • High level of English fluency or native English speaker.
    • Ability to multitask and prioritize effectively in a fast-paced environment.
    • Strong work ethic and capability to work collaboratively within cross-functional teams.

If you are a skilled medical writer with a passion for scientific communication and meet the qualifications above, we invite you to apply for this exciting opportunity.