About Intercept Pharmaceuticals

Intercept Pharmaceuticals, Inc. is an American biopharmaceutical company incorporated in 2002, focusing on the development of novel synthetic bile acid analogs to treat chronic liver diseases, such as primary biliary cirrhosis (PBC) now called primary biliary cholangitis, non-alcoholic fatty liver disease (or non-alcoholic steatohepatitis, NASH), cirrhosis, portal hypertension, primary sclerosing cholangitis and also the intestinal disorder, bile acid diarrhea.

About the role

Elevate your career by joining the world's growth industry. Thrive in an environment that fosters positive relationships and recognizes outstanding performance! We know you want to feel valued every single day and be recognized for your contribution. At Intercept Pharma, we strive to empower our employees and effectively engage your involvement in our success.

Responsibilities

• To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements.
• To review outsourced intermediates for regulatory adequacy to support Procurement Team in vendor selection.
• To coordinate with Chemical Research Department, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies.
• To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner.
• Demonstrates good R programming skills
• Can participate in development of new standard CM functionalities. Tasks can involve gathering of requirements, programming, testing and documentation.
• Can design, develop and lead development of study specific CM analyses. Tasks can involve gathering of requirements, programming, testing, documentation, coordination of work of other involved personnel.
• Can design, develop and lead development of data mapping to CM functionalities. Tasks can involve gathering of requirements, programming, testing, documentation and coordination of work of other involved personnel.
• Can be responsible for maintenance of data mapping and study specific CM analyses to ensure they continue to work in line with requirements; acts as a subject matter expect
• Identifies opportunities to improve deliveries and best practice
• Provides practical solutions for problems
• Leads delivery of specific tasks with other CM staff
• Can contribute to function by training and mentoring of more junior staff
• Can lead activities related to development of CM functionalities for a study or project

Candidate requirements

Educational degree (B.tech/BSc/Msc/PhD) in Life Science, Computer Science or Information Science and 2 years of experience in the application of information and knowledge management in a clinical or scientific setting, or equivalent combination of education and experience

Has good knowledge of R programming language

• Good communication skills in both written and spoken English
• Team player
• Has basic knowledge of SQL

Desirable

Knowledge of Hadoop is an advantage

Contact us to apply

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.