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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing the Medical, Legal, and Regulatory (MLR) process, including experience with Veeva Vault PromoMats and MedComms. Proficient in scientific writing, project management, and ensuring compliance with healthcare regulations.
Highest-signal resume keywords
MLR Project ManagementVeeva Vault PromoMatsScientific WritingHealthcare ComplianceMeeting Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Scientific ReviewingProject PlanningQuality AssuranceDocument ManagementTime Management
Soft Skills
Effective CommunicationCustomer ServiceAttention to DetailIndependenceFlexibility
Tools & Technologies
Veeva Vault ScribeMicrosoft Office SuiteOutlook
Industry Keywords
Life SciencesBiomedicalFDA 2253US Drug AdvertisingMedical Terminology
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Manage the end-to-end Medical, Legal and Regulatory (MLR) process for a dedicated client
- Schedule, set agendas for, and lead Review Committee meetings
- Add live discussion notes in Veeva Vault Scribe meeting minutes, circulate draft minutes for Committee approval, and finalize and file approved minutes
- Ensure covered communications are properly vetted through online review systems such as Veeva Vault PromoMats and Vault MedComms
- Cascade and enforce new policies and guidelines related to material review
- Verify materials are assigned to the appropriate review path
- Reject incomplete or non-review-ready submissions
- Facilitate and document discussions in live meetings
- Quality-check final documents against approved documents
- Support FDA 2253 submissions and country-specific regulatory submissions with the MLR Regulatory Reviewer/Partner
- Support development of project plans and medical content development teams
- Support uploading materials into clients’ review and approval platforms, including annotating and anchoring references
- Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives
- Contribute to process improvement and customer service associated with the MLR review process
- Perform other duties as assigned
Requirements
What you’ll need- Graduates in any Life Sciences / Biomedical field
- Excellent ability to communicate effectively in English, both orally and in writing
- At least 2 years of experience in a healthcare agency or pharmaceutical company
- Experience with Veeva Vault PromoMats / MedComms
- Experience in Scientific Writing / Scientific Reviewing / MLR Project management
- Time management
- Meeting management
- Excellent customer service skills
- Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications)
- Working knowledge of or familiarity with global healthcare compliance statutes and laws preferred
- Ability to perform assignments with a high degree of independence requiring extensive experience, skill, and knowledge
- Proven ability to manage multiple tasks, set priorities and meet deadlines
- Ability to manage cross-functional projects
- Familiarity with laws and regulations regarding US drug / device advertising and promotion, including industry best practices
- Knowledge of medical terminology preferred but not required
- Quality-oriented with consistent attention to detail
- Ability to follow established processes and procedures and adopt new practices and priorities as required
- Able to work full-time and be flexible with work scheduling as required by clients and management
- Graduates/Postgraduates in Pharmacy or Medicine preferred
Benefits
Comp & perks- Competitive salaries and benefits
- Equal Opportunity Employer
- Reasonable accommodation for applicants and employees with disabilities
- Full-time employment
