Job Summary
We are looking for an experienced Senior Medical Writer to author, review, and manage clinical and regulatory documents supporting global drug development programs. The ideal candidate will have expertise in clinical research documentation, regulatory writing, project leadership, and stakeholder management, ensuring the delivery of high-quality documents that meet regulatory and client requirements.
Key Responsibilities
- Author and review clinical and regulatory documents, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.
- Conduct literature reviews and analyze scientific and clinical data to support document development.
- Ensure documents comply with ICH-GCP, FDA, EMA, client requirements, SOPs, and regulatory guidelines.
- Coordinate cross-functional reviews, manage document timelines, and incorporate stakeholder feedback.
- Serve as the Medical Writing representative on project teams and act as a primary point of contact for assigned projects.
- Review statistical outputs and ensure accurate presentation and interpretation of clinical data.
- Perform quality reviews to ensure data consistency, accuracy, and publishing readiness.
- Mentor junior writers and contribute to process improvement, training, and SOP development initiatives.
Required Qualifications
- Bachelor's, Master's, PharmD, MD, PhD, or equivalent degree in Life Sciences, Pharmacy, Medicine, or a related field.
- Must have experience in Medical Writing, preferably within a CRO, pharmaceutical, or biotechnology environment.
- Strong experience authoring clinical and regulatory documents such as Protocols, CSRs, Investigator Brochures, and CTD documents.
- Solid understanding of clinical research, drug development processes, and ICH-GCP guidelines.
- Excellent scientific writing, editing, and communication skills.
- Proficiency in Microsoft Word, Excel, document management systems, and collaborative authoring tools.
