Bioequivalence Expert Pharmaceutical Consultant Job at Pharmavise Corporation, Maple Grove, MN

Y1prcFl5Zk1yNS9ZUCtNTDhRdGZURTFvTXc9PQ==
  • Pharmavise Corporation
  • Maple Grove, MN

Job Description

This is a remote position.

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 at   

 

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.  

EEO Employer:  

Pharmavise   Consulting 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.   Pharmavise   Consulting 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 contact   info@pharmavise.com .  

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

Follow us in LinkedIn for more company updates and opportunities.



Job Tags

Contract work, Remote job,

Similar Jobs

Revival Research Institute, LLC

Event Coordinator Job at Revival Research Institute, LLC

 ...an environment of learning, growth, and community engagement. Job Summary: We are seeking a highly organized and dynamic Event Coordinator to manage and execute all company and community events. The ideal candidate will be responsible for organizing internal events... 

Archway Physician Recruitment

Family Medicine job opening: Staples, MN Job at Archway Physician Recruitment

**Family Medicine opening in Minnesota**Located in ***Staples, MN*** - Brainerd 30m - This is a fantastic opportunity for a physician to play a key role in opening a new clinic!- Our ideal candidate would be interested in serving as a physician leader, be an energetic... 

School of Spanish Italian Portuguese

Teacher of Portuguese/Norwegian/Swedish Job at School of Spanish Italian Portuguese

 ...Obtained Masters degree (or above);Teaching related working experience for no less than 2 years;The experience could be exempted if one has obtained the degree of Education, Language, or Pedagogy. Teaching Portuguese (or Norwegian/Swedish) to undergraduate students.

University of Pennsylvania

Steamshift Operator Job at University of Pennsylvania

 ...Steamshift Operator University Overview The University of Pennsylvania...  ...2023. Penn offers a unique working environment within the city of...  ...is the perfect place to call home for work and play. The...  ...and General Motors, cellular phone service plans, movie tickets,... 

JPMorgan Chase Bank, N.A.

Quantitative Modeling Job at JPMorgan Chase Bank, N.A.

 ...Duties: Design, develop, test and validate statistical/economic models for portfolio risk, including probability of default, loss...  ...modeling lifecycle. QUALIFICATIONS: Minimum education and experience required: Master's Degree in Statistics, Mathematics, Econometrics...