Shakti Ranjan Rath
Senior Manager Ii (Cell Therapy) - Line Manager @百时美施贵宝
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WORK HISTORY
Senior Manager Ii (Cell Therapy) - Line Manager @百时美施贵宝
Hyderabad, IN
Develop and communicate strategic direction for the group to ensure that the worldwide regulatory documentation supports BMS R&D goals and objectives.• Establish strategic partnership with other functions within BMS to maintain fully integrated and standardized processes and systems and a complete alignment of roles and responsibilities to meet BMS R&D objectives and priorities.• Lead scientific writers in producing high quality documents based upon good documentation principles within established optimum timelines.• Proactively and fluidly manage the group to take advantage of unplanned opportunities and overcome unforeseen obstacles, while achieving milestones.• Set clear performance standards, provides feedback and coaching, identifies and fulfill training needs, and hold the group members accountable for key deliverables. Manages performance together with relevant cross-functional project team leaders.• Coordinate employee development to build individual capability and understanding of organizational breadth and depth. Enable the group to proactively identify and take advantage of career development opportunities.• Assess resource requirements for all projects, assign resources according to BMS R&D priorities, and prepare criteria and strategies for the selection and maintenance of external documentation support for documents not covered adequately by in-house resources. · • Author and Review regulatory, clinical, and safety documentation according to good documentation principles (organization, clarity, scientific standards) • Develop training on regulatory documents from a variety of disciplines and provide to writers regardless of reporting relationship in matters pertaining to documentation processes and principles. Develop resources for writing team to ensure quality standards. · • Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.
EDUCATION
Roland Institute of Pharmaceutical Sciences (RIPS), Berhampur
B. Pharmacy
College of pharmaceutical sciences, Berhampur
M.Pharmacy, Pharmaceutical Chemistry
SKILLS
ABOUT SHAKTI RANJAN RATH
A result driven, high-energy, hands-on professional, with a successful record of accomplishments in the field of regulatory medical writing (more than 15 Years). Rich experience in writing, reviewing, and quality checking of a broad range of regulatory and safety deliverables including submission documents (e.g, clinical overviews, summaries of clinical efficacy, and safety), clinical study reports (CSRs), protocols and protocol amendments, informed consent forms (ICFs), investigator brochures (IBs), patient narratives, development safety update reports (DSURs), RMP Updates, and pediatric investigational plans (PIPs). Well versed with relevant ICH, USFDA, and EMEA guidelines. Thorough knowledge of American Manual of Style, clinical pharmacokinetics, and biostatistics. Major strengths include excellent communication skills, strong team player, attention to detail, and dutiful respect for deadlines. Proficient in MS Word, MS Excel, MS PowerPoint, and MS Outlook. Well versed with electronic document management systems (e.g, CREDI, SubWay Clinical) and advanced review tools (e.g, PleaseReview)
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