| Job open for Regulatory Data Readiness Specialist || Remote || at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1919385&uid= Job Title: Regulatory Data Readiness Specialist Location Remote Job Description: Responsibilities A. Competencies Strong Knowledge and demonstrated understanding of following: Departmental standard operating procedures Business Practices o Client standards, practices, policies and business Strong knowledge of the drug development process, regulatory affairs, and submissions management Ability to work independently with minimal supervision Ability to work under pressure and meet business critical deadlines Experienced problem solver Ability to critically analyse technical and/or scientific issues Ability to offer support, guidance and coaching to junior team members B. Skills Excellent written and verbal communication - English essential, other languages desirable but not required unless regionally specified Good organizational skills Flexible and adaptable to change Demonstrates good judgement and business acumen working with clients or internal teams Strong interpersonal skills Ability to negotiate, influence others and work in a cross functional team Ability to work under pressure and meet business critical deadlines Highly familiar with regulations and guidelines in the US, EU and/or MOW markets Networking Skills Ability to objectively assess personal strengths and weaknesses adjust to improve performance Good Project Management skills C. Training Mastery of MS Office Skill-Set: Word, Excel and other tools as appropriate Core Professional Skills Training (e.g. corporate etiquette, email writing, etc.) Regulatory Affairs University (completion of GSA related tracks) Experience with Document Management, Regulatory Information Management, Publishing or other related systems Additional Professional Skills as applicable (Presentation Skills, Project Management) Train the Trainer (as applicable) Lean Six Sigma Trained, Tested / Greenbelt Training D. Characteristics Self-motivated, hard-working, proactive, good interpersonal skills, builds global relationships, displays good judgment Learns quickly, actively listens, adjusts and improves by considering and processing constructive feedback, Works in a positive collaborative manner with all level colleagues, peers and clients Demonstrates business acumen and has strong problem solving skills E. Qualifications & Certifications Bachelors Degree (or equivalent) in any Discipline may be acceptable Masters Degree, PhD or another advanced degree (or equivalent) beneficial at this level but not essential F. Experience Typically a minimum years relevant regulatory experience within a regulatory function Experience with RIM, Submission Management or Publishing tools Demonstrated experience in Operational role Data Management, Publishing, Submissions Management Solid Project Management skills Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards . Warm Regards Iyyappaswamy Sr Resource Manager Tekshapers Inc 850 Stephenson Hwy, Suite 205 , Troy, MI 48083 (W): 248-565-4747 Ext -144 ; (C): -+1-248-306-8440 Email: [email protected] | https://www.tekshapers.com/ MBE Certified | ISO 9001:2008 | Tekshapers is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. * Disclaimer: This E-Mail may contain Confidential and/or legally privileged Information and is meant for the intended recipient(s) only. If you have received this e-mail in error and are not the intended recipient/s, kindly notify us at [email protected] and then delete this e-mail immediately from your system. You are also hereby notified that any use, any form of reproduction, dissemination, copying, disclosure, modification, distribution, and/or publication of this e-mail, its contents, or its attachment/s other than by its intended recipient/s is strictly prohibited and may be unlawful. Internet communication cannot be guaranteed to be secured or error-free as information could be delayed, intercepted, corrupted, lost, or contain viruses. Tekshapers. does not accept any liability for any errors, omissions, viruses or computer problems experienced by any recipient as a result of this e-mail. -- Keywords: cprogramm information technology microsoft Michigan Job open for Regulatory Data Readiness Specialist || Remote || [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1919385&uid= |
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| 10:03 PM 11-Nov-24 |