Medical Content And Review Specialist

2+ years

Not Disclosed

Pune

10 Nov. 7, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Content and Review Specialist

Location: Remote (U.S. Only)
Company: EVERSANA

About EVERSANA
At EVERSANA, we’re proud to be recognized as a Great Place to Work across the globe. With a vision to create a healthier world, we are dedicated to delivering innovative commercialization services to the life sciences industry. Our team of over 7,000 employees works with more than 650 clients, ranging from dynamic biotech startups to large pharmaceutical companies. Together, we help bring groundbreaking therapies to market and improve the lives of patients worldwide.

Our strength lies in the diversity of our workforce—embracing varied backgrounds and experiences. We believe that our employees are the driving force behind the culture we cultivate, and we’re always looking for passionate individuals to join us in shaping the future of healthcare and life sciences. At EVERSANA, every contribution counts in making a meaningful impact.

Position Overview

We are seeking a Medical Content and Review Specialist to manage the Medical, Legal, and Regulatory (MLR) review process for a dedicated client. In this role, you will ensure that all promotional and non-promotional materials are accurate, compliant, and ready for publication. You will oversee the MLR process from start to finish, coordinating meetings, facilitating discussions, and ensuring timely and effective execution of all deliverables.

Key Responsibilities

MLR Process Management

Oversee the end-to-end MLR review process for all materials, ensuring compliance with internal and external policies and regulations.
Schedule, set agendas, and lead Review Committee meetings, ensuring that all materials undergo proper review in the online system (e.g., Veeva Vault PromoMats and Vault MedComms).
Add live discussion notes during meetings and ensure that all comments are documented accurately.
Draft, circulate, and finalize meeting minutes for approval, ensuring all records are filed and archived appropriately.
Verify that all submitted materials are complete and properly assigned to the correct review path, rejecting incomplete or unreview-ready submissions.
Conduct quality checks to compare the final document to the approved version.
Support FDA 2253 submissions in partnership with the MLR Regulatory Reviewer.

Medical Content Support

Assist with the development of project plans and provide administrative support for the medical content team.
Support the upload of materials into clients’ review and approval platforms, including annotation and referencing.

Medical Affairs & Project Management

Assist the Medical Affairs and Medical Information teams in the management and execution of project plans for key initiatives.

Job Expectations

Metrics: Contribute to process improvements that positively impact MLR review metrics.
Customer Service: Maintain and improve service quality related to MLR review activities.
Time Management: Ensure timely completion of all MLR coordination tasks.
Hours: Full-time position with flexibility in scheduling to accommodate client and management needs.
Travel: This position does not require travel.

Qualifications

Required

Education: Bachelor's degree in a Life Sciences or Biomedical field.
Experience: At least 2 years of experience in a healthcare agency or pharmaceutical company, with a focus on MLR review processes.
Skills:
- Proficiency in Veeva Vault PromoMats/MedComms.
- Strong project management, time management, and meeting management skills.
- Excellent customer service skills, with the ability to communicate effectively in both written and oral forms.
- Computer proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

Preferred

Education: Postgraduate degree in Pharmacy, Medicine, or related field.
Experience:
- Familiarity with global healthcare compliance laws and regulations, particularly in drug/device advertising and promotion.
- Previous experience with scientific writing or reviewing in an MLR context.
Skills:
- Ability to manage cross-functional projects and prioritize tasks effectively.
- Knowledge of medical terminology (preferred but not required).

Cultural Beliefs at EVERSANA

Patient Minded: We act with the patient’s best interest at heart.
Client Delight: We take ownership of every client experience and its impact on results.
Take Action: We are empowered and accountable for our actions.
Embrace Diversity: We foster an environment of respect and inclusivity.
Grow Talent: We own our development and support the growth of others.
Win Together: We collaborate across boundaries to achieve our goals.
Communication Matters: We ensure transparency through thoughtful and timely communication.
Always Innovate: We are bold and creative in everything we do.

Additional Information

Compensation: EVERSANA offers competitive salaries and benefits, with compensation determined by experience and geographic location.

Important Notice:
We are aware of fraudulent job offers misrepresenting EVERSANA. Please note that we will never request personal information or payment during the hiring process. Any suspicious activity should be reported immediately.

EVERSANA is an Equal Opportunity Employer. We value diversity and are committed to fostering an inclusive environment where all individuals feel respected and empowered. We welcome candidates from all backgrounds to apply.