Medical and Scientific Reviewer
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: 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, woman’s 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 client’s 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 patient’s 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 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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Medical and Scientific Reviewer
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: 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, woman’s 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 client’s 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 patient’s 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 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.
Follow us on LinkedIn | Twitter