Specialist Document Coordinator-Quality Reviewer for Regulatory and Safety Documents

Role Overview: You will be joining as a Senior Associate/Specialist Document Coordinator, supporting the Global Medical Writing Team in delivering its portfolio effectively and efficiently. Your main responsibilities will include managing the quality review of clinical and regulatory documents, such as Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, Clinical Summary documents, PBRER, DSUR, and RMP. Key Responsibilities: - Conduct quality review of clinical and regulatory documents - Participate in meetings related to medical writing, quality control, and compliance activities - Collaborate cross-functionally to continuously improve medical writing processes - Familiarity with the AMA style guide - Maintain a flexible attitude towards work assignments and new learning - Work within a team in a collaborative and supportive role Qualifications Required: - A graduate or postgraduate degree in a relevant field such as BPharm, MPharm, BDS (Dental), BSc, MSc, MD, or PhD, or an equivalent combination of job experience - Excellent written and spoken English, including medical terminology - 2-5 years of experience in the pharmaceutical industry with relevant scientific and regulatory knowledge - Knowledge of ICH/Good Clinical Practices, CTD guidance, and GVP guidance Additional Company Details: The company values diversity, inclusion, and a flexible working culture. They believe in creating access and opportunities for personal development and career advancement. The team is composed of curious minds from diverse backgrounds, perspectives, and life experiences, driving excellence, innovation, and a culture of inclusion and belonging that impacts millions and empowers everyone to champion human progress.,