Medical Writer

Responsible for creating, editing, and reviewing a variety of scientific documents, including clinical study protocols, investigator brochures, clinical study reports, and regulatory submissions. Work closely with the Director of Research and various stakeholders to ensure the accuracy, clarity, and compliance of all medical writing materials.

DUTIES AND RESPONSIBILITIES:

Document Preparation:

• Develop, write, and edit high-quality scientific and clinical documents, including but not limited to study protocols, informed consent forms, clinical study reports, and presentations for internal and external stakeholders.
• Collaborate closely with investigators and research teams to gather necessary information and ensure documents are comprehensive and scientifically sound.

Research and Analysis:

• Conduct thorough literature reviews and synthesize relevant scientific data to support document creation.
• Maintain an up-to-date understanding of medical and scientific literature to inform writing projects.

Regulatory Compliance:

• Ensure all written materials comply with regulatory requirements, institutional policies, and guidelines such as Good Clinical Practice (GCP) and Ethics Committee mandates.
• Stay informed about the latest regulatory standards and industry trends impacting medical writing.

Collaboration:

• Work closely with the Director of Research and other stakeholders to develop project timelines and ensure timely completion of documents.
• Build strong working relationships with various departments to facilitate efficient data flow and communication.

Quality Assurance:

• Review and edit documents for clarity, consistency, grammar, and adherence to formatting guidelines, ensuring high-quality outputs that meet scientific standards.
• Incorporate feedback from peers and supervisors and make necessary revisions in a timely manner.

Project Management:

• Manage multiple writing projects simultaneously, tracking progress and ensuring adherence to deadlines.
• Organize and prioritize tasks effectively to meet project and departmental goals.

QUALIFICATIONS & SKILLS:

• Bachelor’s degree in Life Sciences, Medical Writing, or related field; Master’s degree preferred.
• Minimum of 3 years of experience in medical writing or scientific writing, preferably in a clinical or healthcare environment.
• Exceptional writing, editing, and verbal communication skills with an ability to convey complex scientific information clearly and concisely.
• Strong analytical skills with the ability to interpret and summarize clinical data.
• Proficient in Microsoft Office Suite; experience with medical writing software (e.g., EndNote, Reference Manager) is a plus.
• Familiarity with regulatory requirements and medical terminology relevant to clinical research.

Note: Only shortlisted applicants will get contacted.