Clinical Scientist Consultant - Established Products

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.  

 

Main Job Tasks and Responsibilities:

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.

 

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 Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

 

Who will you be working for?

 

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

 

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

 

 

Key words: Clinical Research, Clinical, analytical, investigational, and organizational skills.

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