Medical and Scientific Reviewer

EVERSANA

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profile Job Location:

Pune - India

profile Monthly Salary: Not Disclosed
Posted on: 15 hours ago
Vacancies: 1 Vacancy

Job Summary

THE POSITION:
At EVERSANA we provide end-to-end integrated global medical information and medical affairs services
for various life sciences companies including pharmaceutical biotechnology medical device digital
therapeutics and over-the-counter companies of various sizes including industry leaders and emerging
companies. Additionally we provided therapeutic area support across oncology hematology rare
diseases immunology cardiology dermatology urology gastroenterology infectious diseases
nephrology neurology pain rheumatology respiratory ophthalmology endocrinology pulmonology
hepatology consumer products womans health and more.
This position will be part of our global medical content development and medical / scientific review team.
This role requires medical and scientific expertise an understanding of regulations and best practices for
promotional and non-promotional materials high attention to detail and medical / scientific accuracy the
ability to analyze / translate / interpret scientific literature and data the ability to quickly learn new
therapeutic areas and excellent communication skills (both verbal and written).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

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

  • Perform scientific data fact-checking and review of promotional and non-promotional materials that are submitted for medical legal and regulatory (MLR) review meetings.
  • Ensure that data are scientifically accurate contextually correct editorially accurate and are

presented in a fair/scientifically balanced manner with minimal supervision and in a timely manner:

    • Ensures scientific accuracy relevance and completeness of data
    • Ensures claims and data are clinically and statistically relevant and presented in a scientifically balanced manner (not false or misleading)
    • Ensures that claims are adequately supported by data
    • Determines acceptability of references
    • Advises on whether claims are consistent with the approved label
    • Ensure that the piece is relevant and of utility for the target audience
  • Ensure that information and data presented aligns and are consistent with the clients medical strategy for the review of promotional and non-promotional materials across different therapeutic areas and brands to ensure that materials are of high quality and in compliance with applicable laws and regulations industry standards and best practices.
  • Review materials proofread and check medical content/claims against references.
  • Collaborate and partner with internal or client medical signatory reviewers to ensure alignment and timely and efficient turnaround of material review.
  • Collaborate with material owners / sponsors and other MLR team members to resolve findings in collaboration with the medical signatory reviewer.
  • Identify communicate and resolve issues impacting timelines.
  • Propose recommendations for content and process improvements that could reduce recurring errors and issues.
  • Work with EVERSANA and/or client-provided document management technology platforms (i.e. Veeva PromoMats / MedComms) as content owner when appropriate uploading documents and providing reference anchoring and annotations as required.
  • Collaborate with the Head of Medical Content Development / Medical Affairs / Medical Information and contributes to discussions on strategy tactical execution and communication approaches for assigned projects.
  • Participate in key client meetings as assigned.
  • Support content creation for Medical Affairs Medical Information and Medical Communications including but not limited to Scientific Response Documents (SRD) Frequently Asked Questions (FAQ) documents Slide Sets Abstracts Posters Education and Training materials for current and other potential clients.
  • Support client document development process from gathering materials and developing

scientifically rigorous content to facilitating document review and discussions at medical legal and regulatory (MLR) review meetings.

  • Support creating/updating SOPs checklists templates style guides and guidance documents as necessary.
  • Work collaboratively with other cross-functional medical and scientific reviewers medical writers and creative teams across EVERSANA.
  • All other duties as assigned.
  • Responsible to deliver CLIENT DELIGHT.
  • Responsible to work collaboratively with EVERSANA medical information and medical affairs teams and taking direction and feedback from management and clients.
  • Responsible to ensure management and compliance with industry standards and codes of practice.
  • Able to work independently to support the development of high-quality scientifically accurate strategically aligned ethical and compliant promotional and non-promotional content.
  • Responsible for proactively flagging and managing any quality issues and ensuring timely corrective and preventive actions.
  • Travel Up to 10%.
  • Hours Average 40 hours/week
  •  
  • MINIMUM KNOWLEDGE SKILLS AND ABILITIES:
  • The requirements listed below are representative of the experience education knowledge skill and/or abilities required.

  • PharmD (or M. Pharm. or M.S. Pharm) Ph.D. BDS MDS or MBBS with relevant experience in scientific writing and/or reviewing.
  • Minimum of 2 years of experience in document QC and/or scientific writing within the life science and/or pharmaceutical industry.
  • Experience conducting literature searches and analysis and working with tools such as RightFind PubMed Ovid Embase etc.
  • Strong scientific and medical acumen and ability to grasp complex therapeutic areas (e.g. rare diseases immunology oncology / hematology gene therapy).
  • Understanding of medical terminology clinical trials and drug development process.
  • Ability to analyze and interpret scientific and medical data and translate it for different audiences (e.g. HCPs payers patients / caregivers).
  • Highly detailed orientated and excellent time management skills.
  • Exceptional communication skills including written oral interpersonal and presentation skills including the ability to independently interpret and summarize complex results.
  • Experience using content development and management tools and review / approval platforms (e.g. Veeva Vault PromoMats / MedComms).
  • Ability to effectively interface with all levels of management and staff and to succeed in a matrix team setting while meeting or exceeding timelines.
  • Proficient editing skills along with expertise in Microsoft Office Acrobat and other applications.
  • Strong understanding of regulatory requirements and best practices concerning Medical Information Medical Affairs and promotional and non-promotional materials review.
  • Excellent project management skills and proven track record of being results-driven; ability to manage.
  • Highly Principled - Proves to be a professional of unquestionable integrity credibility and character who demonstrates high moral and ethical behavior.
  • Collaboration Ability to work cross-functionally across EVERSANA business units and with various clients including leadership and various departments and functions of our clients.
  • Agile learning Ability to support and learn about multiple disease states and therapeutic areas.

Qualifications :

Experience developing and/or reviewing promotional and non-promotional content and
materials.
Experience working across multiple therapeutic areas.
Experience working with Veeva Vault MedComms / Promomats.
Understanding of US Regulations and Laws governing pharmaceutical marketing and
promotional and non-promotional materials.
Direct Medical Affairs / Medical Information / Medical Communications / Scientific
Communications experience.


Additional Information :

OUR CULTURAL BELIEFS:

Patient Minded I act with the patients best interest in mind.  

Client Delight I own every client experience and its impact on results.  

Take Action I am empowered and empower others to act now.  

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.  

Embrace Diversity I create an environment of awareness and respect.  

Always InnovateI 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 EVERSANAs 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 ones identity. All of our employees points of view are key to our success and inclusion is everyones responsibility.

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Remote Work :

Yes


Employment Type :

Full-time

THE POSITION:At EVERSANA we provide end-to-end integrated global medical information and medical affairs servicesfor various life sciences companies including pharmaceutical biotechnology medical device digitaltherapeutics and over-the-counter companies of various sizes including industry leaders an...
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About Company

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 ... View more

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