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Medical Writer

3-5 years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: BA/BE/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 the structured job description for the Medical Writing (MW) Department in the BA/BE & Clinical Trials area:


Department

BA/BE & Clinical Trials

Qualification

  • Graduate, Postgraduate, or Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or an equivalent field.
  • Fluency in English is essential.

Mode of Work

On-premise


Job Description

1. Medical Writing Activities

  • Manage and coordinate overall Medical Writing (MW) activities performed by the MW department.
  • Author and review key study documents, including:
    • Protocols
    • Informed Consent Forms (ICFs)
    • Clinical Study Reports (CSRs) for Phase I-IV studies (e.g., PK, FIM, BE/BA, Safety).

2. Cross-Functional Collaboration

  • Work collaboratively with departments such as Clinical Operations, Medical Affairs, QA, and Project Management to ensure timely and high-quality deliverables.

3. Compliance and Quality Assurance

  • Ensure all MW activities align with Advity’s Research Policies, SOPs, and applicable guidelines.
  • Collaborate with the Quality Assurance (QA) team to develop, revise, and implement Standard Operating Procedures (SOPs) as needed.

4. Project Management

  • Set up and monitor project timelines using departmental scheduling tools.
  • Ensure timely execution of assigned tasks while adhering to established schedules.

5. Sponsor and Stakeholder Engagement

  • Represent Advity in discussions with sponsors, clients, and during conferences or client meetings.

6. Training and Knowledge Maintenance

  • Acquire and maintain up-to-date knowledge of national and international guidelines.
  • Participate in and contribute to training sessions for skill and knowledge enhancement.

7. Safety and Miscellaneous

  • Ensure work practices are safe for yourself and your colleagues.
  • Perform other duties as assigned by management, in alignment with your training and expertise.

This role is ideal for individuals with strong organizational, collaborative, and technical writing skills, who thrive in a compliance-driven environment.

Would you like me to help refine this further or add details such as key performance indicators (KPIs)?