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Principal Medical, Regulatory and Clinical Quality Assurance Advisor

 
Requistion ID:  135
Location: 

Deerfield, Illinois, US

Date:  Jan 30, 2019
 

At Lundbeck, we believe life is too precious to be interrupted by brain disorders. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. We pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer's disease and Parkinson's disease. 

 

For Lundbeck, making a meaningful difference for patients is more than an aspiration; it is a commitment that shapes everything we do. Patient advocacy is at the core of who we are and motivates every individual at Lundbeck. Our engagement with the communities we serve grants us better understanding of the needs of patients and their families; and that drives us to develop innovative therapies and impactful programs for patients and caregivers.

 

 

SUMMARY:

The purpose of this position is to work within and support the Medical Regulatory and Clinical Quality Assurance Division (MRC) in assuring compliance of established processes and procedures with relevant regulatory requirements and Lundbeck standards; to act as a lead auditor and manage assigned global audit activities, in line with the MRC QA audit strategies and procedural framework; and to provide relevant MRC QA oversight and support for clinical trial and inspection activities, both in the US and globally.

 

ESSENTIAL FUNCTIONS:

  • Plans, conducts, reports and follows up on assigned routine and/or directed audits, in line with MRC QA steering documents including providing input to the audit schedules and preparing project audit plans.
  • Acts as MRC QA lead in line with MRC QA steering documents, as assigned.
  • Provides GCP/PV expertise and compliance advice in areas related to International Clinical Research (ICR) including Pharmacovigilance (PV) and Clinical Pharmacology, as applicable.
  • Supports training of Auditors within MRC QA, in association with the Head of MRC QA. Provides ICH GCP and applicable regulatory training within the organization and at Investigator meetings, as needed.
  • Supports and/or coordinates GCP and Pharmacovigilance Regulatory Authority inspections, as applicable.
  • Contributes to the maintenance of procedures and processes related to the respective area and the continual improvement of these processes to keep them up to date and in line with best practices and regulations.
  • Functions as MRC QA contact person for CRO and partner clinical quality collaborations.
  • Represents MRC QA division with assigned special projects.
  • Provides input to the generation of MRC QA metrics and trending information, interpretation and recommendations.

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Bachelor’s degree 
  • 8+ experience within the Pharmaceutical or Biotech industry
  • 6+ years Good Clinical Practice (GCP), or relevant auditing experience
  • Experience in leading projects and working within matrix organizations
  • Strong understanding of applicable GCP/ PV regulations - ICH, FDA Code of Federal Regulations, European and international regulations
  • Demonstrable organizational, analytical, and problem solving skills
  • Ability to work independently with minimal supervision, but also work effectively as part of a team
  • Excellent written and oral communication skills with the ability to produce detailed audit reports and to professionally present thoughts and ideas
  • Ability to maintain awareness of relevant legislation, regulatory requirements and industry guidelines
  • Ability to interact with and effectively influence personnel at all levels of the organization

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited Bachelor’s or Master's degree in pharmacy, nursing, biology, chemistry, pharmacology, or related subject
  • Certified Quality Auditor, Lead Auditor Certification or ISO certification
  • Experience with various international regulations, cultures and markets

 

TRAVEL

  • Willingness/Ability to travel approximately 45% of time with some international travel required.


Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain diseases, so every person can be their best. 

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.