Regulatory Data Readiness

Job Description: Job Title: Regulatory Data Readiness Location - Remote Pay Range: $35 - $38.00/hr on W2 Key Skills - Veeva vault Enrichment /data readiness skills Responsibilities A. Competencies Strong Knowledge and demonstrated understanding of following: *** Regulatory Standards *** Regulatory Practice Departmental standard operating procedures Business Practices 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 Bachelor's Degree (or equivalent) in any Discipline may be acceptable Master's 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.

Created: 2024-11-16