| Regulatory Affairs with Precision Medicine-Parkway,NJ(Remote) at Remote, Remote, USA |
| Email: [email protected] |
| Hello Friends , I Hope you are doing well. This is Surya from Humac Inc. , Please check the following job description, and if you are interested, or know someone who might be interested, please share your updated resume to reach you. Role: Regulatory Affairs with Precision Medicine Location: Parkway,NJ (Remote) Degree / Experience Requirements: Bachelors degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience Key Competencies Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team development. Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives. Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor. Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functions. Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies. Ability to apply project management techniques within teams and effectively manage meetings. Demonstrated ability to breakdown complex, scientific content into logical components. Ability to coordinate global activities, facilitate issue resolution and conflict management. Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks. Demonstrated ability to negotiate with and influence others. Understanding of strategic and tactical role for the drug development process. Understanding of general global regulatory requirements for drugs in development. Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points. -- Best Regards, Sai Surya Teja US IT Recruiter Humac Inc. P: (623)-748-4074 E: [email protected] | W: www.humacinc.com LinkedIn: linkedin.com/in/sai-surya-1b22a721b Phoenix, AZ 85027 Keywords: rlang information technology Arizona New Jersey Regulatory Affairs with Precision Medicine-Parkway,NJ(Remote) [email protected] |
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| Mon Aug 26 18:59:00 UTC 2024 |