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.
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.
Follow us on LinkedIn Twitter
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...
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.
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.
Follow us on LinkedIn Twitter
Remote Work :
Yes
Employment Type :
Full-time
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