Clinical Scientist Consultant- Established Products

at  ClinChoice

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Clinical Scientist Consultant- Established Products to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

EDUCATION AND EXPERIENCE:

• MS, MPH, PharmD, PhD or equivalent clinical training/experience required.
• A minimum of 3 years’ experience working in clinical research in academia or the pharmaceutical industry.
• Excellent analytical, investigational, and organizational skills.
• Cross-functional experience in complex projects.
• Good interpersonal skills to interact with key team members and extract needed information.
• Experience using clinical trials applications, such as v-Trial Master File, Madidate, and Interactive Web Response System

The Clinical Scientist, Established Products (CS-EP), is involved in supporting Compound Development Team Leaders and Clinical Leaders in the lifecycle management of a variety of marketed products across 4 Therapeutic Portfolios consisting of Internal Medicine/Infectious Diseases, Immunology & Cardiopulmonary, Neuroscience, and Oncology. The CS-EP position is dedicated to maximizing the value of the Therapeutic Portfolios by providing active scientific contribution to cross-functional clinical teams to enable worldwide registrations for new indications and enhancements to product labels.

• Supports Clinical Teams in the fulfillment of clinical trials and projects as required by Health Authorities worldwide.
• Assists Clinical Leaders in executing clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications.
• Participates in cross-functional teams for evaluation of new product ideas, reviews medical literature and related new technologies.
• Collaborates with internal stakeholders on providing support for interactions with internal and external experts/thought leaders and oversight of Investigator Initiated Studies.
• Partners with Clinical Leaders, Global Labeling Teams, Regulatory Affairs and Safety to update the Core Data Sheets, EU, US and other local labels for products within the EP Therapeutic Portfolios.
• Performs tasks in assisting Clinical Leaders with preparation of clinical study reports; submission dossiers; responses to requests from Health Authorities worldwide; registration studies conducted by operating companies; and timely implementations of corrective actions as needed.
• Other duties will be assigned by Compound Development Team Leaders and Clinical Leaders, as appropriate, such as reviewing Confidential Company Information (CCI) and Yale University Open Data Access (YODA) requests.