Associate Medical Writer

Job Description

The Associate Medical Writer will work under the guidance and mentorship of experienced Medical Writers to support the timely delivery of high-quality clinical and regulatory documents. Responsibilities include contributing to the preparation of study protocols, clinical study reports (CSRs), investigator brochures (IBs), ICH M25/M27 documents, and other clinical, scientific, and regulatory documentation.

Key responsibilities include:

• Support the development, editing, formatting, and quality review of clinical, scientific, and regulatory documents in accordance with client requirements, internal standards, and applicable regulatory guidelines.
• Participate in project-related teleconferences and meetings, and coordinate meeting logistics as required.
• Prepare and distribute meeting minutes, action items, and follow-up communications.
• Assist in drafting and revising medical, scientific, regulatory, and procedural documents, including standard operating procedures (SOPs).
• Perform quality checks (QC) on documents prepared by Medical Writers and Senior Medical Writers to ensure accuracy, consistency, and compliance with established standards.
• Collaborate effectively with cross-functional teams to support project delivery timelines and quality objectives.
• Maintain document quality, version control, and project records in accordance with company procedures.

Job Requirements

Education

• Master's degree in Pharmacy, Medicine, Life Sciences, or a related scientific discipline.
• Advanced degrees such as an MD, PharmD, or PhD are preferred.

Qualifications and Skills

• Excellent written and verbal communication skills in English.
• Strong attention to detail and commitment to delivering high-quality work.
• Excellent organizational, planning, and time-management skills.
• Proficiency in Microsoft Office applications, including Word, PowerPoint, Excel, and SharePoint.
• Strong analytical, problem-solving, and critical-thinking skills.
• Ability to manage multiple tasks and priorities in a fast-paced environment.
• Ability to work independently as well as collaboratively within a team environment.

Experience

• Prior experience in a pharmaceutical company, CRO, or related healthcare industry is preferred but not required.
• Entry-level candidates with strong scientific writing skills and relevant academic training are encouraged to apply.