Medical Writer

Position: Medical Writer I / Senior Medical Writer

Experience Required: 6 to 8 years (CRO preferred / Pharma)

Qualification: M. Pharm (Pharmacology) / Pharm D

Location: Remote (Work from Home)

Job Type: Full-time, Remote

Key Responsibilities (Must-Have Skills)

- Independently prepare, review, and finalize Protocols

- Concept Sheets

- Investigators Brochure (IB)

- Informed Consent Forms (ICF)

- Case Report Forms (CRF)

- Ensure compliance with regulatory requirements

Nice-to-Have Skills

- Module 2 (CTD) Documents

- Regulatory briefing documents

- Manuscripts and publications

- Scientific presentations / posters

- Experience with global teams

Role & responsibilities

• Act as the primary point of contact for medical writing projects within CBCC.
• Independently prepare, review and finalize the concept sheets.
• Prepare the Clinical Study protocols in compliance to applicable regulatory requirements and associated study documents like

  ICF, CRF, IB

  etc.
• Independently prepare, review and finalize the Module 2 documents such as clinical and non-clinical overview and summaries
• Review of SAP and study results-
• Prepare, review and finalize SEC presentations in consultation with Medical Monitor and other stakeholders.
• Prepare regulatory documents such as briefing document, controlled correspondence or scientific advise, regulatory application for orphan drug, fast track designation, accelerated approval etc.
• Review Clinical study report and study report compilation in compliance to applicable regulatory requirements.
• Prepare manuscripts for peered reviewed publications. Prepare abstracts, slide presentations and poster presentations for scientific meetings within and outside India.
• Work within CBCC to assist with the review and preparation of summary documents that support the clinical/scientific needs of a project.
• Interact with all stake holders like PM, DM, Biostatistics, Medical Monitor, QA etc. involved in the document preparation.
• Ensure that accurate, high-quality documents are prepared on schedule as per project timeline.
• Ensure compliance with the Quality standard requirement of quality management system and relevant documentation and filing.
• Ensure proper team management.
• Review & finalization of study specific Project Management plans, in consultation with respective Project Manager.
• Any other task assigned by HOD/Designee.