Senior Medical Document Specialist

10 hours ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title:

Regulatory Medical Writer

Job Description:

  • We are seeking an experienced Regulatory Medical Writer to join our team. As a key member of our medical writing department, you will be responsible for drafting and managing clinical documents such as Protocols, Investigators Brochures (IB), Informed Consent Documents (ICD), and other regulatory submission documents.
  • You will also prepare and review key regulatory documents including the Non-clinical Overview (Module 2.4), Clinical Overview (Module 2.5), Module 2.6, Module 2.7, and briefing documents. Develop ISS and ISE text summaries.

Responsibilities:

  1. Drafting & Management: Independently draft and manage clinical documents such as Protocols, Investigators Brochures (IB), Informed Consent Documents (ICD), and other regulatory submission documents.
  2. Preparation & Review: Prepare and review key regulatory documents including the Non-clinical Overview (Module 2.4), Clinical Overview (Module 2.5), Module 2.6, Module 2.7, and briefing documents. Develop ISS and ISE text summaries.
  3. Briefing Packages: Draft Pre-IND, Pre-NDA briefing packages, SAM briefing packages, orphan drug designation feasibility reports, and expedite approval processes.
  4. Document Support: Review and support clinical trial-related documents (e.g., SAP, Mock TLFs, eCRF outlines, study-specific documents).
  5. Medical Writing Coordination: Manage medical writing activities for individual studies, coordinating with departments with minimal supervision.
  6. Content Creation: Develop impactful and accurate content for various deliverables for clients, adhering to client expectations and deadlines through teamwork and scientific expertise.

Required Skills and Qualifications:

  • Experience: Minimum of 10+ years as a professional medical writer with extensive experience in drafting and managing regulatory medical writing documents.
  • Regulatory Knowledge: Expert understanding of regulations, policies, and guidelines applicable to regulatory medical writing.
  • Technical Proficiency: Proficient in Word, PowerPoint, Excel, and Adobe Acrobat, with advanced knowledge of PDF editing and compilation tools.
  • Publication Knowledge: Basic understanding of the publication process and congress activities.
  • Communication Skills: Excellent interpersonal and communication skills for effective liaison with internal teams, clients, KOLs, and other key stakeholders.
  • Attention to Detail: Keen eye for accuracy and high fluency in English.
  • Work Ethic: Ability to multitask, prioritize effectively, and work collaboratively within a cross-functional team.

About the Job:

This is a challenging opportunity for a highly skilled Regulatory Medical Writer to take on a leadership role in our medical writing department. If you have a strong background in regulatory medical writing and are looking for a new challenge, we encourage you to apply.

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