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Required – Senior Lead Research Scientist!
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Senior Lead Research Scientist  15002882 
For Us, It’s A Mission
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate.  If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.
 
Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:
 
  • Serves as PK scientific lead responsible for assembly, understanding and presenting study-specific information regarding the drug product for projects assigned.  Applies scientific methodology and proposes solutions to formulation/bioequivalence hurdles based on interpretation of previous results of BE & PK studies and or information gathered from other sources.  Provide scientific feedback to other departments as needed.
  • Create and/or Reviews Protocols for Clinical Studies for different dosage forms (ie OSD, dermatologics, injectables, and respiratory).  Assembles review of literature, reporting and summarization with respect to PK characterization.
  • Train CRO staff (or CRAs) on Protocol, answer questions on study design, and monitor studies and/or collaborate with Clinical Research Associates (CRAs) to ensure studies are monitored and conducted appropriately from a PK perspective.  Ensure study documentation is written accurately.
  • Collaborate with Bioanalytical Lab regarding assay development, moieties to be measured, suitable assay range, sample handling procedures and study execution.
  • Assist Program Manager, Quality Specialist and Product Development regarding planning of all aspects of clinical trial conduct and subsequent reporting timelines.
  • Review data in collaboration with Statistics for: subject exclusion, time deviations and PK characteristics.  Review study results, develop and prepare discussion section with appropriate interpretation of the data.  This requires integrating theories and rationale to support conclusion(s) and their meaning(s).
  • Assume responsibility for preparation and assembly of final BE & PK reports, assist in preparation and review of electronic submissions, and review and signoff of final BE & PK reports
  • Assume responsibility in generating answers to Health Authority questions or addressing Citizen’s Petitions with respect to Pharmacokinetics and clinical trial related queries.  Recommend and prepare data presentations and additional statistical information, as required.
  • Assist supervisor as needed.
 

 

Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:
  • A combination of experience and/or education will be taken into consideration.  Doctorate degree (Ph.D.) with at least 5 years of experience, a Master’s degree with 9 or more years of experience, or a Bachelor’s Degree with at least 15 years of experience working in Pharmacokinetics or clinical trials preferred.  Pharmacokinetics or Industrial Pharmacy background, preferred.    
  • Must possess in-depth knowledge of US CFR, SOPs and Health Authority (ex. FDA, EMA, TGA, TPD) regulations and industry guidance across multiple dosage forms.
  • Must possess strong analytical and complex problem solving skills. Must possess strong writing, communication, and presentation skills. Must be able to manage multiple projects, have strong computer skills and a working knowledge of Microsoft Office Suite, PK Statistical Program, Sigma Plot, and Lotus Notes..
  • Position reports directly to Director or Senior Director.  There are no direct reports to this position.  Position acts as a corporate resource.  Position functions independently with supervision as needed.  
  • Registered Pharmacist, considered desirable
  • Ability to read and interpret comprehensive and intricate research documents.  Ability to write scientific reports and technical correspondence.  Ability to work with executives and communicate abstract concepts.   Ability to present to a high level of the organization and groups outside of the organization.
  • Ability to solve equations, apply technical mathematical concepts, and perform complex computations.  Ability to understand and interpret statistics. Ability to use and understand mathematical modeling in order to draw appropriate conclusion(s).  Must have a good understanding of statistical design concepts
  • Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.  Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
  • Proficiency in speaking, comprehending, reading and writing English is required. 
 
Why Mylan?
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 30,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.
 
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.

 

Schedule

  Full-time

Job Posting

  Oct 20, 2015, 2:35:31 AM

Unposting Date

  Ongoing



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