Location
King of Prussia, PA | United States
Job description
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 Senior Medical Evaluator? This position is located in our King of Prussia PA, Marburg Germany, Bern Switzerland or any other CSL office. It is a Hybrid role. You will report to the Global Medical Evaluation Lead.
You will provide guidance and clinical expertise on all aspects of individual case assessments throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during early clinical development and prioritizing cases in late-stage development and post marketing. You will apply analysis and interpretation of complex clinical safety data
You will identify potential challenges, risks and roadblocks associated with individual case assessments. Product knowledge and deep experience managing the complex safety issues of biologicals are needed for success in the role.
You will work with important high-level partners, contributes to, and approves regulatory reports / submissions / queries.
Responsibilities: - Under supervision, responsible for setting technical medical strategies for these global projects and therapeutic areas, consistent with functional expectations.
- Identify potential challenges, risks and roadblocks associated with the global medical strategy and work in developing solutions to address these, working and inter-functionally with other departments.
- Identify tools necessary to facilitate risks and to implement necessary risk management initiatives.
Qualifications: - MD (Medical Doctor degree) or international equivalent plus accredited residency.
- Two (2) years minimum experience as a physician in patient care.
- Five (5) years pharmaceutical / CRO industry experience, of which at least (2) are in a medical evaluation role, with broad overview of all aspects of a PV system and experience in regulatory requirements.
BENEFITS - Medical, Dental Vision
- 401K
- Paid time Off
#LI-Hybrid
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.
Do work that matters at CSL Behring!
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Salary