Instagram
youtube
Facebook

Senior Medical Writer

3+ years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time Education: 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

Job Title: Senior Medical Writer
Location: Hyderabad, India
Job Type: Full-Time


About the Role

As a Senior Medical Writer at Perceptive, you will play a pivotal role in preparing, reviewing, and coordinating the production of clinical documents that support independent reviews, regulatory submissions, and medical communications. You’ll contribute to improving the biopharmaceutical industry by bringing treatments to the market faster.


Key Benefits

  • Health:

    • Comprehensive medical plan for employees and dependents.
    • Personal accident and life insurance.
    • Critical illness cover.
  • Wealth:

    • Flexible salary structure.
    • Provident fund contributions (12%).
    • Gratuity scheme.
  • Growth Opportunities:

    • Access to internal training and professional development programs.

Responsibilities

Content Authoring:

  • Develop and finalize clinical documents for regulatory and non-regulatory purposes.
  • Conduct literature reviews to gather background information.
  • Draft and revise documents based on team feedback.
  • Ensure compliance with applicable guidelines, regulations, SOPs, and templates.

Project Management:

  • Serve as the primary client contact for medical writing projects.
  • Lead authoring team meetings and manage timelines.
  • Coordinate reviews and approvals of draft documents.
  • Identify and address project challenges, ensuring timely delivery.

Quality Management:

  • Perform content and copyediting reviews.
  • Ensure documents meet FDA, EMA, or other regulatory standards.
  • Maintain documentation consistency and integrity.

Relationship Management:

  • Implement stakeholder communication strategies.
  • Resolve issues and provide corrective actions.
  • Enhance customer and stakeholder relationships.

Additional Duties:

  • Participate in process improvement initiatives.
  • Support marketing efforts such as abstracts, posters, and white papers.

Skills and Attributes

  • Strong interpersonal, verbal, and written communication skills.
  • Ability to prioritize tasks and produce high-quality documents.
  • Adaptable, detail-oriented, and methodical in a fast-paced environment.
  • Critical thinking and problem-solving abilities.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint).
  • Experience with data analysis tools (e.g., Tableau, Power BI) is a plus.

Qualifications

  • Education: Bachelor’s degree in a technical discipline (science, pharmacy, nursing, or related health field preferred).

  • Experience:

    • Professional experience in medical writing, regulatory documentation, or clinical research.
    • Knowledge of ICH-GCP and industry regulations.
    • Familiarity with Agile methodologies and regulated environments.
  • Language Proficiency:

    • Fluent in English (written and verbal).
    • Proficiency in additional languages is desirable.

Why Join Us?

At Perceptive, we are committed to fostering an inclusive, diverse, and supportive workplace. Your work will have a tangible impact on the healthcare industry, improving outcomes for patients worldwide.

Slug: senior-medical-writer