Clinical Research Scientist II

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Our Team, Your Impact

The Scientist Clinical (BR Therapeutic Equivalence Coordinator) is responsible primarily for the delivery of pharmaceutical equivalence studies (PE)/ biowaivers studies (BWV)/ comparative dissolution profile (CDP) studies in support of generic product development or post-approval for submissions in the BR and other markets as needed.

This position may also support management, and reporting of Phase 1 bioequivalence/clinical  

How You’ll Spend Your Day

Plan and manage PE/BWV/CDP studies conducted by a hired CRO. Work with the CRO responsible for study execution, to ensure that all deliverables are received as per the agreed upon timelines and current legal requirements.

Conduct audits and monitoring visits of CROS CROS (may include travel).

Evaluation of technical documents related to product pharmaceutical R&D and BD dossiers according to BR requirements and strategy of PE/BWV/CDP studies to determine scope of said studies.

Actively participate in project team meetings and provide technical support for Generic product development and new products (when necessary).

Purchase of materials for PE/BWV/CDP studies and organize shipment to the hired CRO according to service agreement requests (main materials: analytical standards of API/impurities, chromatography materials and other consumables for pharmaceutical analysis). Development of material suppliers when necessary. Manage the process of hiring a CRO to conduct PE/ BWV/CDP studies and management of service agreement

Technical support to CROs during method transfer and analytical activities of PE/BWV/CDP studies, acting as a focal point in technical discussions with product R&D. Analyze and interpret results generated during these studies. Approve final PE/BWV/CDP reports and provide deficiency support to Regulatory Affairs on said reports when required. 

Your Skills and Experience

Experience: 

• Extensive Pharmaceutical Equivalence (PE) experience (at least 5 years of analytical method development/validation) and knowledge of PE and analytical method validation Brazilian requirements. It is preferable to have some previous knowledge/experience in Bioequivalence (BE)


• Able to plan, organize, coordinate and manage tasks efficiently 


• Strong knowledge and experience in physicochemical analyses, instrumental analysis (chromatography techniques, mass spectrometry, among others) and bioanalyses.


• Solid knowledge and experience in analytical method development, analytical metho validation and bioanalytical method validation.


• Solid knowledge in chemistry applied to pharmaceutical development related to generic products and pharmaceutical research.


• Strong knowledge in Quality Assurance applied to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).


• Experience in process, project, and people management applied to analytical R&D, Quality Control, Quality Assurance, Pharmaceutical Equivalence, Bioequivalence, and Clinical Research within the Pharmaceutical Industry.


• Solid knowledge in MS Office pack, SAP System (including Ariba System).

Education: University Degree in the field of Pharmacy, Chemistry, Biology, Health and Science or any related fields 

Skills: 

• Good communication skills and ability to work collaboratively within a team environment on both a local and global level.


• Candidate is expected to evaluate complex technical information and be able to work with various global R&D teams and local CROs to conduct PE/BWV/CDP studies effectively.

Language: 

• English language proficiency


• Advanced Spanish (Nice to have)

How We’ll Take Care of You

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