At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
Acts as CMC lead/specialist for client projects, may have CMC responsibility for a portfolio of products.
Conducts CMC change control assessments
Provides regulatory strategy of CMC submissions worldwide
Authors and reviews Module 3 sections
Prepares and reviews CMC documentation required to support submissions e.g IMPD updates, MAA, post approval variations and renewals.
Manage own work load, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.
Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters
May prepare and deliver training, as appropriate.
Performs other tasks or assignments, as delegated by Regulatory management.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
Knowledge of variations/renewals/procedures in Europe and/or emerging markets
Complete understanding of the content and typical level of detail in Module 3.
Conducted CMC Change Control Assessment – determine if regulatory action is required and if so determine the strategy, documentation requirements and timelines;
Preparation of technical justifications to support variations – prepared in collaboration with technical experts
Manage cross functional interactions with supervision to support CMC activities;
Prepare and review Module 3 CTD sections for regulatory submissions (variations, renewals, responses to RA assessments);
Experience of product development/manufacturing or analytical work is strongly preferred
Be able to manage own workload
Ability to work to tight timelines
Adaptable to change
Excellent verbal and written communication skills
Excellent computer skills e.g. Word, Excel
Experience of using document management and change control systems
Good team player
Project management experience an advantage
MINIMUM EDUCATION AND CERTIFICATION(S)
Bachelor of Science Degree in life science related discipline
Minimum 2 years regulatory CMC experience, focusing on marketed products in Europe and/or emerging markets
Did You Know?
* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute
Primary Location: Great Britain
Organization: GBR02 - UK Product Development