Bioequivalence Expert Pharmaceutical Consultant

Pharmavise Corporation; United States; A distancia; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Descripción de la vacante

Pharmavise Corporation seeks a bioequivalence expert to provide consultation on study design, conduct, and interpretation for pharmaceutical clients. You will review protocols and SAPs to ensure regulatory compliance (FDA/EMA/ICH) and oversee PK analyses using WinNonlin or SAS.

Collaboration with regulatory, clinical and QA teams is essential to deliver robust bioequivalence programs. The role requires an advanced degree in pharmaceutical sciences or PharmD with at least 5 years of related

Formación

• Advanced degree in pharmaceutical sciences or PharmD with bioequivalence focus.
• Minimum 5 years in bioequivalence study design and conduct.
• Strong PK/PD modeling, regulatory knowledge, and global market familiarity.

Responsabilidades

• Provide expert consultation in bioequivalence study design, conduct, analysis and interpretation.
• Review SAPs, protocols, and study reports for regulatory compliance (FDA, EMA, ICH).
• Design and oversee bioequivalence studies for generic products and select study designs.
• Perform PK and statistical analyses using WinNonlin or SAS.
• Prepare regulatory submissions and responses for bioequivalence data.
• Advise on bioanalytical method development and validation for PK studies.
• Stay updated on regulatory requirements and best practices in bioequivalence.
• Collaborate with regulatory, clinical development and quality teams for program success.

Conocimientos

Bioequivalence

Study design

Statistical analysis

WinNonlin

SAS

PK/PD modeling

Regulatory knowledge

Communication skills

Regulatory affairs

Educación

PhD in pharmaceutical sciences

PharmD

Equivalent degree

Herramientas

WinNonlin

SAS

Descripción del empleo

Location: United States

Category: Medical Device

Location:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us atwww.pharmavise.com

Responsibilities:

1. Provide expert consultation and support in bioequivalence study design, conduct, analysis, and interpretation to pharmaceutical companies and contract research organizations (CROs).

2. Review study protocols, statistical analysis plans (SAPs), and study reports to ensure compliance with regulatory requirements and guidelines (e.g., FDA, EMA, ICH).

3. Design and oversee bioequivalence studies for generic drug products, including selection of appropriate study designs, endpoints, and statistical methods.

4. Conduct pharmacokinetic (PK) and statistical analyses of bioequivalence data using software such as WinNonlin or SAS.

5. Prepare and review bioequivalence sections of regulatory submissions, including abbreviated new drug applications (ANDAs), bioequivalence study reports, and responses to regulatory inquiries.

6. Provide guidance on bioanalytical method development and validation for bioequivalence studies.

7. Stay abreast of emerging regulatory requirements, scientific advancements, and best practices in bioequivalence and generic drug development.

8. 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.

This is a challenging and rewarding opportunity for individuals passionate about bioequivalence and generic drug development. Competitive compensation packages are available.

Be part of our network of Subject Matter Experts.

EEO Employer:

PharmaviseConsulting Corp. is an equal opportunity employer. We 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.PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable 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 .

PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you joinPharmavise, you become part of a team that values Excellence Through Quality.

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