Associate Director Medical Affairs Biostatistics

4 weeks ago

Americas USPA King of Prussia CSL Behring, United States CSL Behring Full time

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Associate Director, Medical Affairs Biostatistics. The job is located in the King of Prussia office. This is a hybrid position. You will report to the Director, Medical Affairs Biostatistics

You will support product launch of pipeline assets and life-cycle management of marketed products by generation of scientifically valid information from clinical trials and real-world data. You will be a member of the team and contribute to the strategic and operational decisions for one or multiple theurapeutical areas (TAs). You will provide statistical support to Medical Affairs, Market Access, Health Economic Outcome Research (HEOR) within CSL Behring.

Responsibilities:

  • Manage the office function to support compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country and regional regulations for reporting adverse events to regulatory agencies.
  • Develop and implement pharmacovigilance guidelines and ensures the uniform and processing of adverse event data on all marketed products in development.
  • Be a liaison internally and with external collaborators to develop programs to meet regulatory reporting requirements.
  • Prepares reports for company management and external regulatory agencies.
  • May provide medical evaluation of adverse event reports.
  • Helps prepare new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports.
  • May work with data management in the ongoing development of databases

Qualifications:

  • Bachelor's degree, Medical Documentation, or equivalent in a life science discipline
  • 10 years Pharmacovigilance experience in multinational pharmaceutical industry
  • 6+ years experience in a leadership role
  • Experience of local/international regulations and PV processes
  • Experience with regulatory inspections
  • Experience in administration of complex data sets
  • Experience in project-managing CAPA and SOP development

BENEFITS

  • Medical, Dental Vision
  • 401K
  • Paid time Off

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Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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