Service Delivery Ops Associate Manager

Skill required: Regulatory Services - Life Sciences Regulatory Affairs
Designation:Service Delivery Ops Associate Manager
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:10 to 14 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 699,000 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? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. 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. You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc.
What are we looking for? •Results orientation •Strong analytical skills •Written and verbal communication •Commitment to quality •Agility for quick learning
Roles and Responsibilities: •In this role you are required to do analysis and solving of moderately complex problems • Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures • The person requires understanding of the strategic direction set by senior management as it relates to team goals • Primary upward interaction is with direct supervisor or team leads • Generally interacts with peers and/or management levels at a client and/or within Accenture • The person should require minimal guidance when determining methods and procedures on new assignments • Decisions often impact the team in which they reside and occasionally impact other teams • Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture • Please note that this role may require you to work in rotational shifts