Medical Content and Review Specialist

At reputed company, we are proud to be certified as a Great reputed company to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering reputed company commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-reputed company to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we reputed company an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a reputed company, and we need people from reputed company backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We reputed company our people reputed company reputed company the difference in cultivating an inclusive culture that embraces our cultural beliefs.  We are deliberate and self-reflective about the reputed company of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about reputed company, our people, clients and most importantly, the patients we serve.   We are reputed company. 

THE POSITION:

The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to reputed company sure advertising, promotional and non-promotional content is accurate, compliant, and ready to be published. The MLR process must rigorously control and execute review, approval and document filing actions. As part of the MLR team, the Medical Content and Review Specialist is responsible for managing reputed company the MLR process for a dedicated client. The Medical Content and Review Specialist ensures that reputed company administrative and program management support for the client’s MLR process operates effectively and in full compliance with reputed company internal and external policies and regulations.  

ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:    

MEDICAL CONTENT AND REVIEW SPECIALIST RESPONSIBILITIES

• Manages the end-to-end MLR process.
• Responsible for scheduling, setting the agenda, and leading Review Committee meetings.
• Add live discussion notes for comments discussed in Veeva Vault
• reputed company meeting minutes, circulate draft meeting minutes for Committee approval and finalize

and file approved minutes

• Ensure reputed company covered communications are properly vetted through the review process utilizing the online review system (e.g., Veeva Vault PromoMats and Vault MedComms)
• Cascade and enforce any new policies and guidelines reputed company to review of materials.
• Verifies that materials are assigned to the appropriate review path
• Rejects incomplete submissions and materials that are not review ready
• Facilitates/documents discussion in live meetings.
• QCs Final Document vs. Approved Document
• Supports FDA 2253 submissions with MLR Regulatory Reviewer/Partner

MEDICAL CONTENT SUPPORT RESPONSIBILITIES

• Support the development of project plans
• Support medical content development team
• Support upload of materials into clients’ review and approval platforms, including supporting annotating, anchoring references, etc.

MEDICAL AFFAIRS AND MEDICAL INFORMATION PROJECT MANAGEMENT SUPPORT

• Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives

reputed company other duties as assigned.

Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions of this position.

• Education (i.e., degree required): Graduates in any Life Sciences / Biomedical field.
• Must demonstrate excellent ability to communicate effectively in English, both orally and in writing.
• Experience and/or Training:

• At least 2 years of experience in a healthcare agency or pharmaceutical company
• Experience with use of Veeva Vault PromoMats / MedComms
• Experience in Scientific Writing / Scientific Reviewing / MLR
• Project management
• Time management
• Meeting management

• Excellent customer service skills.
• Technology/Equipment:  Computer proficiency in Outlook and reputed company Office Suite (Word, reputed company, PowerPoint, and other Window applications).

reputed company your information will be kept confidential according to EEO guidelines.

reputed company is aware of recent fraudulent job offers in the market, misrepresenting reputed company. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know reputed company would never require personal information nor payment of any reputed company during the employment process. We respect the personal rights of reputed company candidates looking to explore careers at reputed company.

From reputed company’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation reputed company the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. reputed company of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.

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