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
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- 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.