Must Have Technical/Functional Skills:
Excellent interpersonal and written and verbal communication skills
Strong analytical skills and expertise in writing and review of scientific/clinical documents.
Proactive, flexible, meticulous with attention to detail
Excellent Planning, coordination and organizational skills and ability to drive initiatives
Good listening as well as leadership skills.
Ability to mentor and coach associates.
Manage & foster cultural sensitivities. Experience in managing team members from diverse cultures
Influencing, Problem solving, good negotiation and Client Management skills
Subject matter Expert must have a strong business knowledge and experience, some management skill, effective communication, leadership, decision making skills.
Keep abreast with industry trends and disseminate CMC knowledge in regulatory domain.
Develop framework for CMC competency development to enable individual development plan for associates in the regulatory domain across accounts.
Provide CMC inputs to determine training needs and contribute to regulatory domain specific training needs.
Development/Review of CMC training modules, dashboards, reusable/productivity tools development and constant upgradation.
Develop CMC Training material and impart the trainings for the project teams for competency development.
Authoring of white papers, manuscripts to establish Industry thought leadership.
Regular interaction and provide support to project teams to enhance quality of deliverables and compliance to CMC SLAs.
Will act as a go to person to delivery teams for any CMC technical clarifications and advise with reference to regulatory filing and authoring strategies for drug substances and drug products.
Provide CMC expert guidance for transition of projects from client(s) especially during early project initiation or new scope implementation.
Mentoring/Coaching associate(s) for CMC domain activities. Act as guide coach counsellor for the RA team.
Contribute with regulatory CMC domain inputs for development of automation tools, platforms, new industry solutions.
Inculcate culture of automation, innovation, process improvement. Facilitate sharing CMC best practices in domain across projects to increase efficiency as measured by saving in time, cost, and delivery of high-quality documents.
Standardization of CMC metrics and setting benchmarks across projects.
Development and update of CMC SOP(s), work instructions and templates for regulatory domain
Drive and monitor CMC initiatives across accounts for the regulatory domain