Coordenador De Bioequivalência E Projetos Relacionados

The Coordinator role includes: The coordinator leads the bioequivalence and related projects for Knight products. Depending on the products and the requirements, the projects can include but not limited to pharmacological equivalence, comparative bioavailability, comparative bioequivalence, bioexemption, and comparative dissolution studies.

Responsibilities: Strategy and operations:

Plan and provide strategic guidance on bioequivalence and related projects by mastering health authorities' regulations in LATAM. Translate knowledge about bioavailability (BA), pharmacodynamic (PD), pharmacokinetic (PK) and dissolution methods to guide Knight product development. Design studies:

Design studies to demonstrate bioequivalence of Knight products in collaboration with clinical research organization, as required. Monitor, track, and ensure diligent project execution by CROs. Support ethics committee submission as required. Documentation:

Collect documentation to comply with regulatory submission and Good Clinical Practices (GCPs). Review clinical documentation including (non-exclusive list): Clinical Study Protocols, case report form (CRF), Informed consent form (ICF), Statistical Analysis Plans, and Clinical Study Reports (CSRs). Supply chain:

Assess the needs of supplies to conduct the required studies. Liaise with the Supply and Quality departments to ensure material availability on time for study conduct. Support to ensure readiness of the import and/or export documentation. Operations optimization:

Develop mitigation and contingency plans to optimize operations. Address questions from Health Authorities relating to bioequivalence and related studies. CRO collaboration:

Map all CROs to conduct pharmacological equivalence and bioequivalence studies (clinical, bioanalytics, and biostats) in LATAM. Prepare and review in collaboration with legal Master Service Agreement (MSA), service agreements, and confidentiality agreements with the service providers. Compliance:

Comply with ICH and GCP requirements. Develop and update SOPs and working instructions to meet GCP requirements. Develop and comply with internal SOPs, policies, and ethical standards. Stakeholder collaboration:

Develop and maintain relationships with internal stakeholders, CROs, and regulators. Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork. Qualifications: Advanced science degree (PhD, PharmD, MSc) in:
Drug Development Clinical trial Development Desirable: Broad knowledge of FDA, WHO, ANVISA and other LATAM agencies regulations and guidelines, as well as GCP/GLP and ICH. Experience: 5 years of relevant experience in bioequivalence. Demonstrated knowledge of regulatory environment relating to demonstration of therapeutic equivalence. Significant experience in reviewing Clinical Study Protocols, Statistical Analysis Plans, and Clinical Study Reports.


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