* Job Family: Medical & Regulatory Affairs
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. 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 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.
We embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds to help build the future of healthcare and the life sciences industry. We look for team members that care deeply about EVERSANA, our people, clients, and the patients we serve.
Job Description
THE POSITION:
The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to ensure 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, ensuring that all administrative and program management support 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. The job holder must be legally eligible to work in the European Union or the UK.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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.
* Reject 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 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 require travel.
Qualifications
* Education: Graduates in any Life Sciences / Biomedical field.
* 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, and meeting management skills.
* Technology/Equipment: Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Windows applications).
PREFERRED QUALIFICATIONS:
* Education: Graduates/Postgraduates in Pharmacy or Medicine preferred.
* Working knowledge of or familiarity with global healthcare compliance statutes and laws.
* Ability to perform assignments with a high degree of independence.
* 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.
* Positive attitude and energy.
* Excellent communication skills.
* Innovative mindset.
* Highly principled.
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.
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