Bioequivalence Expert Pharmaceutical Consultant

3 weeks ago

Maple Grove, Minnesota, United States Pharmavise Corporation Full time
Job Title: Bioequivalence Expert Pharmaceutical Consultant

This is a remote position that offers a challenging and rewarding opportunity for individuals passionate about bioequivalence and generic drug development.

About the Role:

We are seeking a highly skilled Bioequivalence Expert Pharmaceutical Consultant to join our team at Pharmavise Consulting Corp. As a key member of our cross-functional team, you will provide expert consultation and support in bioequivalence study design, conduct, analysis, and interpretation to pharmaceutical companies and contract research organizations (CROs).

Responsibilities:
  1. Review study protocols, statistical analysis plans (SAPs), and study reports to ensure compliance with regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
  2. Design and oversee bioequivalence studies for generic drug products, including selection of appropriate study designs, endpoints, and statistical methods.
  3. Conduct pharmacokinetic (PK) and statistical analyses of bioequivalence data using software such as WinNonlin or SAS.
  4. Prepare and review bioequivalence sections of regulatory submissions, including abbreviated new drug applications (ANDAs), bioequivalence study reports, and responses to regulatory inquiries.
  5. Provide guidance on bioanalytical method development and validation for bioequivalence studies.
  6. Stay abreast of emerging regulatory requirements, scientific advancements, and best practices in bioequivalence and generic drug development.
  7. Collaborate with cross-functional teams, including regulatory affairs, clinical development, and quality assurance, to ensure successful execution of bioequivalence programs.
Qualifications:
  1. Advanced degree (PhD, PharmD, or equivalent) in pharmaceutical sciences, pharmacokinetics, or related field.
  2. Minimum of 5 years of experience in bioequivalence study design and conduct within the pharmaceutical industry, CRO, or regulatory agency.
  3. Deep understanding of bioequivalence principles, study methodologies, and regulatory requirements in major markets (e.g., US, EU).
  4. Proficiency in pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation techniques.
  5. Experience with bioanalytical method development and validation for PK studies.
  6. Strong analytical and problem-solving skills, with the ability to interpret complex PK data and statistical analyses.
  7. Excellent communication and presentation skills, with the ability to effectively convey technical information to diverse audiences.
  8. Regulatory affairs certification (RAC) or relevant professional certification (e.g., DABT, CCRP) preferred but not required.
About Us:

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. We value Excellence Through Quality and are committed to ensuring our clients exceed their compliance goals while improving patient health and safety.

We are an equal opportunity employer and do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com.

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