Job description
Company Description
At EVERSANA, we are proud to be certified as a Great Place 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 next-generation 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-ups 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 make 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 priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind 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 EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.
Job Description
THE POSITION:
The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to make 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 all the MLR process for a dedicated client. The Medical Content and Review Specialist ensures that all administrative and program management support for the client’s MLR process operates effectively and in full compliance with all internal and external policies and regulations.
The role is home office based, (full-time position), ideally located in Poland, Germany, Ireland, the UK, Italy, Portugal, or Spain and the job holder must be legally eligible to work in the European Union or the UK.
Please note: Must be flexible to work US hours.
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
- Scribe meeting minutes, circulate draft meeting minutes for Committee approval and finalize and file approved minutes
- Ensure all 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 related 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
- Helps establish and/or update MLR SOPs
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
All other duties as assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
EXPECTATIONS OF THE JOB:
- Metrics: Maintain and contribute toward process improvement which positively impacts metrics associated with activities of the MLR Review process; metrics are subject to change annually or more often as deemed necessary.
- Customer Services: Maintain and improve customer services associated with the activity of the MLR review.
- Time Management: Complete MLR coordination responsibilities in a timely manner.
- Hours: Able to work full-time and be flexible with work scheduling as required by clients and management.
- Travel: In general, this position does not travel
Qualifications
- 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 writin
- 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 Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications).
PREFERRED QUALIFICATIONS:
- Education: Graduates/Postgraduates in Pharmacy or Medicine preferred.
- Experience and/or Training:
- Working knowledge of or familiarity with global healthcare compliance statutes and laws.
- Ability to perform assignments with a high degree of independence requiring extensive experience, skill, and knowledge
- Excellent computer skills including competency in presentation, word processing, and spreadsheet software, utilizing MS Office Suite.
- Proven ability to manage multiple tasks, set priorities, and meet deadlines
- Ability to manage cross-functional projects
- Familiar with laws and regulations regarding US drug/device advertising and promotion, including industry best practices
- Knowledge of medical terminology (preferred but not required).
- Must be quality-oriented and demonstrate consistent attention to detail.
- Must have the ability to follow established processes and procedures and the flexibility to adopt new practices and priorities as required.
- Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others, and a sense of humor. Energizes others and heightens morale through her/his attitude.
- Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and create a climate that motivates and encourages others to participate.
- Innovator – Transforms creative ideas into original solutions that positively impact the company’s performance.
- Highly Principled – Proves to be a professional of unquestionable integrity, credibility, and character who demonstrates high moral and ethical behavior.
Additional Information
Patient Minded I act with the patient’s best interest in mind.
Client Delight I own every client experience and its impact on results.
Take Action I am empowered and hold myself accountable.
Embrace Diversity I create an environment of awareness and respect.
Grow Talent I own my development and invest in the development of others.
Win Together I passionately connect with anyone, anywhere, anytime to achieve results.
Communication Matters I speak up to create transparent, thoughtful, and timely dialogue.
Always Innovate I am bold and creative in everything I do.
Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. 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 EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.
From EVERSANA’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 within 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. All of our employees’ points of view are key to our success, and inclusion is everyone’s responsibility.
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