With over 15 years of hands-on experience in the pharmaceutical and clinical research industry, Dorothy Linda Ogwuru is a seasoned Medical Writer known for her commitment to excellence, precision, and purpose. Her career spans diverse therapeutic areas, with deep expertise in both pharmacovigilance and clinical development, enabling her to contribute meaningfully to global healthcare communications.

Dorothy’s technical proficiency includes the authorship and review of a wide range of clinical and regulatory documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), Briefing Books, eCTD modules, Regulatory Responses, INDs, BLAs, and NDAs. In the safety domain, she consistently delivers high-quality documents including PBRERs, DSURs, ACOs, and RMPs, ensuring full compliance with global regulatory standards. She is well-versed in frameworks such as ICH GCP, Volume 9a, EU Clinical Directives, ICH E2F, and E2D, and is highly regarded for her ability to distill complex scientific data into clear, compelling narratives while maintaining accuracy and integrity.

Beyond her work in medical writing, Dorothy is the Founder of PharmaLink Academy; a specialized training platform dedicated to equipping aspiring and professional medical writers with the tools, mentorship, and community they need to thrive. She also serves as the Chief Operating Officer of Costack Spices, an Afro-Caribbean spice brand focused on quality, sustainability, and global impact.

A passionate mentor and speaker, Dorothy is especially committed to empowering women in science, business, and leadership. Whether in boardrooms, classrooms, or global conferences, she continues to lead with vision, inspiring others to pursue transformation, excellence, and lasting legacy.