Principal Regulatory Strategist
2 weeks ago
Responsibilities
- Provide consulting and advisory services for complex regulatory issues or projects.
- Author and maintain documentation as required to sustain regulatory compliance.
- Provide senior technical review for complex regulatory projects.
- Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports.
- Participate on project teams and provide expertise on related regulatory matters.
- Clearly and accurately conveys information to peers, supervisors, and other stakeholders.
- Participates in in implementation of new/updated operational strategies to comply with new/updated policies and recommendations.
- Identifies new/updated policies and recommendations and may provide professional opinions on impact of regulatory changes to MMS and Clients (from the desk of, blogs, webinars, etc.).
- College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
- Minimum of 10 years’ experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA and/or EMA) and FDA REMS.
- Expert knowledge of scientific principles and concepts.
- Reputation as emerging leader in field with sustained performance and accomplishment.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.
Powered by JazzHR
NVdRxCIDIc
-
Principal Statistical Programmer
4 weeks ago
Princeton, United States WCG Full time**Description and Requirements**: **ABOUT WCG**: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and...
-
Principal Statistical Programmer
2 weeks ago
Princeton, United States WIRB-Copernicus Group Full timeABOUT WCG: WCG's clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to...
-
Principal Licensed Site Remediation Professional
3 weeks ago
Princeton, United States Terraphase Engineering Inc Full timeJob DescriptionJob DescriptionDescription:Terraphase is seeking candidates for a senior-level Licensed Site Remediation Professional (LSRP). The desired individual can provide strategic and technical support on client projects and effectively support business development efforts within the firm’s growing environmental investigation/remediation and...
-
Princeton, United States Terraphase Engineering Full timeTerraphase is seeking candidates for a senior-level Licensed Site Remediation Professional (LSRP). The desired individual can provide strategic and technical support on client projects and effectively support business development efforts within the firms growing environmental investigation/remediation and litigation support service areas. The role entails...
-
Princeton, United States Terraphase Engineering Inc. Full timeTerraphase is seeking candidates for a senior-level Licensed Site Remediation Professional (LSRP). The desired individual can provide strategic and technical support on client projects and effectively support business development efforts within the firm’s growing environmental investigation/remediation and litigation support service areas. The role entails...
-
Principal Licensed Site Remediation Professional
1 month ago
Princeton, United States Terraphase Engineering Inc. Full timeTerraphase is seeking candidates for a senior-level Licensed Site Remediation Professional (LSRP). The desired individual can provide strategic and technical support on client projects and effectively support business development efforts within the firm’s growing environmental investigation/remediation and litigation support service areas. The role entails...
-
Principal Licensed Site Remediation Professional
4 weeks ago
Princeton, United States Terraphase Engineering Inc. Full timeTerraphase is seeking candidates for a senior-level Licensed Site Remediation Professional (LSRP). The desired individual can provide strategic and technical support on client projects and effectively support business development efforts within the firm’s growing environmental investigation/remediation and litigation support service areas. The role entails...