Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
Join our team now at Siemens Healthineers as Regulatory Affairs Specialist (Board of Pharmacy Compliance)
This is a role well suited to an ambitious candidate, looking for the next step in their career. As a Regulatory Affairs Specialist, you will be responsible for:
- Completing or assisting in the completion of BOP submissions (e.g., license applications, inspection responses, etc.)
- Assistance with and coordination of activities during regulatory audits (e.g., providing documents/information necessary to support the inspection requests)
- Management of pharmacy investigations and assist with all pharmacy complaints
- Monitoring changes to state Board of Pharmacy (BOP) regulations/laws to ensure a continuous state of compliance
- Development of pharmacy practice procedures and/or related processes to ensure regulatory compliance and operational excellence
- Attending state BOP meetings to represent or present on the behalf of PETNET interests
- Identifying areas unique to nuclear pharmacy and PETNET operations and request necessary exemptions from state-based regulatory oversight
- Support of cross functional activities pertaining to regulatory compliance, including the development of briefing documents
- Education support on regulatory standards for internal and external stakeholders
- Development and oversight of timelines for timely response to regulatory agencies
- Assisting with general Quality and Regulatory tasks as needed (e.g., FDA inspection support, Regional Quality Compliance Specialist (RQCS) support, FDA regulatory submissions, etc.)
This position may suit you best if you are familiar with and acceptant of the aspects below.
- Several years of relevant experience in BOP compliance aspects
- General understanding of PET Drug cGMP requirements and those that relate to the practice of nuclear pharmacy (e.g., USP <825>)
- Good office/computer skills (e.g., Word, PowerPoint, Excel, Outlook, etc.)
- Willingness to travel up to 15% and flexibility on the work schedule
- Good presentation skills for both internal and external interactions
Required skills for success in this role
- BA/BS (or equivalent) with direct experience in regulatory submissions, pharmacy licensing, and pharmacy law (pharmacy degree from an ACPE accredited pharmacy program preferred)
- Minimum of 4 years of regulatory affairs or nuclear operations experience
- High standard of professional ethics, integrity, and trust
- Excellent oral and written communication skills
- Excellent planning, organizational and prioritizing skills
- Consistently high professional image and demeanor
- Strong interpersonal/group skills; capable of working collaboratively with colleagues in all functions
- Attention to detail, accuracy, and timelines
- Ability to effectively multi-task
- Ability to interpret and comply with domestic and international regulatory standards
- Ability to coordinate information from cross-functional disciplines
- Flexible in responding to changing project priorities
- Exercise good judgment in decision-making and sharing of sensitive information
- Strong understanding of the regulatory process
- Flexibility to work on issues of diverse scope
- Responds effectively to meet management objectives
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
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If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: PETNET Solutions, Inc.
Experience Level: Mid-level Professional
Full / Part time: Full-time
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