Assist in responding to regulatory agency queries and document revisions as required.

Perform quality control reviews of documents to ensure consistency, grammar, and adherence to templates.

Ensure that all content meets the highest standards of clarity, accuracy, and scientific integrity.

Provide scientific expertise in interpreting data and transforming it into clear documents and summaries.

Requirements:

A degree in life sciences (e.g., Biology, Pharmacology, Medicine, or related fields) is required; an advanced degree (e.g., MSc, PhD, MD) is preferred.

Extensive experience as a medical writer within a pharmaceutical, biotech, or CRO environment, with experience in authoring clinical and/or regulatory documentation.

Familiarity with drug development processes, regulatory submission requirements, and guidelines.

Experience with clinical trial documentation and regulatory submissions.

Additional Skills:

Excellent written and verbal communication skills, with strong attention to detail and a commitment to accuracy and quality.

Ability to interpret complex scientific data and present it in a clear and concise manner.

Knowledge of clinical research terminology, medical literature, and regulatory guidelines.

Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

Familiarity with medical publishing standards and platforms.

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