Senior Manager 1 Document Coordinator

As the Senior Manager Document Coordinator, you will be a true leader supporting the Global Medical Writing Team to deliver its portfolio effectively and efficiently. Your role will involve overseeing and conducting quality reviews of various clinical and regulatory documents, prioritizing quality checks and compliance activities, representing the QC team in meetings, leading and motivating the Clinical MW team in Bangalore, India, mentoring and training new joiners/junior Document coordinators, participating in key meetings, and collaborating cross-functionally for continuous improvement of standards and best practices for medical writing. Key Responsibilities: - Independently oversee and conduct quality review of clinical and regulatory documents such as Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, and Clinical Summary documents - Allocate and prioritize quality check and compliance activities - Represent QC team in meetings with internal and external stakeholders - Lead and motivate the Clinical MW team in Bangalore, India - Mentor and train the assigned new joiners/junior Document coordinators - Participate in meetings related to key MW, QC, and compliance activities - Collaborate cross functionally for continuous improvement of standards and best practices for medical writing Qualifications Required: - Graduate degree or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts, MD/PhD or advanced science degree - More than 12 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific, safety, and regulatory knowledge - Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide - In-depth knowledge of Clinical, Regulatory, and Safety documents - Profound pharmaceutical industry experience (more than 10 years experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge) required - In-depth knowledge of ICH/Good Clinical Practices, CTD guidance, FDA regulations, and the drug development process - Comprehensive experience in working with cross-functional, global teams, and vendor resources across different regions and time zones - A flexible attitude with respect to work assignments and new learning; readily adapt to changes In this role, you will be joining a diverse, inclusive, and flexible working culture that offers great opportunities for personal development and career advancement across the globe. If you are ready to work your magic and champion human progress, apply now to become a part of a team dedicated to Sparking Discovery and Elevating Humanity!,