LifeScience Regulatory Svs Sr Analyst

Skill required: Regulatory Services - Clinical & Regulatory Writing

Designation: LifeScience Regulatory Svs Sr Analyst

Qualifications: Master of Pharmacy

Years of Experience: 5 to 8 years

About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com

What would you do?

• Assist with data collection and initial drafting of Chemistry, Manufacturing, and Controls (CMC) documents.
• Collaborate with team members to ensure accuracy and completeness of regulatory submissions.
• The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components documents of submission in accordance with ICH guidelines and other Health Authorities review and transform Source Documents Perform Quality Control Document QC checks for all submission components
• Produce variety of clinical documents throughout the lifecycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through to preparing regulatory submission documents including post approval reports. What are we looking for?
• Primary skill - Clinical & Regulatory Writing - P5
• Maintain records of CMC authoring activities in alignment with organizational standards.
• Have understanding on Veeva RIMS and DMS Roles and Responsibilities:
• In this role you are required to do analysis and solving of increasingly complex problems.
• Your day to day interactions are with peers within Accenture.
• You are likely to have some interaction with clients and or Accenture management.
• You will be given minimal instruction on daily work tasks and a moderate level of instruction on new assignments.
• Decisions that are made by you impact your own work and may impact the work of others.
• In this role you would be an individual contributor and or oversee a small work effort and or team.
• Please note that this role may require you to work in rotational shifts