At EVERSANA, our integrated life sciences compliance team is taking a leading role in helping some of the most scientifically advanced biopharma and research companies around the world to innovate novel therapies for rare, ultra‑rare and a range of critical therapeutic areas including oncology, neurology, immuno‑oncology, immunology and more. This role is within the EVERSANA Compliance team and reports directly to the Manager, Medical Content Development. It collaborates closely with other members of the EVERSANA Compliance Business Unit (Medical Information, Medical Affairs, Pharmacovigilance, Regulatory and Quality).
The position will support various types of clients, including pharmaceutical, biotechnology, medical device, digital therapeutics, and over‑the‑counter companies of all sizes, especially small and emerging companies. It is responsible for content development‑related client engagements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Supports the Manager, Medical Content Development on content‑development engagements for integrated and complete commercialization deals as well as for clients who require medical information or medical affairs consulting services outside of EVERSANA’s complete commercialization partnerships.
- Writes and creates medical and scientific content for Medical Affairs, Medical Information and Medical Communications, including Scientific Response Documents, FAQ documents, slide sets, abstracts, posters, education and training materials, and other related documents.
- Drives the client document development process from gathering materials and developing scientifically rigorous content to facilitating document review and discussions at medical, legal, regulatory meetings.
- Works with EVERSANA and/or client‑provided document management technology platforms (e.g., Veeva PromoMats / MedComms) as content owner, uploading documents, providing reference anchoring and annotations as required.
- May perform scientific data fact checking for documents in support of medical reviewers participating in MLR teams.
- Collaborates with the Manager, Medical Content Development and contributes to strategy, tactical execution and communication approaches for assigned projects.
- Participates in key client meetings as assigned.
- Supports preparation of thought‑leadership articles, newsletters, publications, congress presentations, slide decks and blogs related to the medical content services and practices.
- Supports creation/updating of SOPs, checklists, templates, style guides and guidance documents as necessary.
- Mentors and coaches team members; supports hiring and onboarding as needed.
- Stays knowledgeable of industry best practices and supports the leadership team in evaluating and implementing new technologies and procedures to improve operational efficiency and quality of materials developed.
- Works collaboratively with other medical writers and creative teams across EVERSANA.
- Performs all other duties as assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
EXPECTATIONS OF THE JOB
- Responsible to deliver client delight.
- Responsible to identify, deploy, oversee, mentor direct reports and consultants supporting various clients.
- Responsible to work collaboratively with EVERSANA medical information and medical affairs teams and take 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 develop high‑quality, scientifically accurate, strategically aligned, ethical, and compliant medical content.
- Responsible to proactively flag and manage any quality issues, and ensure timely corrective and preventive actions.
- Travel – Up to 10% (only post‑COVID).
- Hours – Average 40+ hours per week.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES
- PharmD, MD, PhD, M. Pharm., or M.S. Pharm with medical writing and content development experience.
- Minimum of 4 years of experience within the life science and/or pharmaceutical industry with extensive medical writing and content development experience.
- Direct experience in Medical Information, Medical Communications or Scientific Communications.
- Exceptional communication skills, including written, oral, interpersonal, and presentation skills, with the ability to independently interpret and summarize complex results.
- Ability to effectively interface with all levels of management and staff and to succeed in a matrix team setting while meeting or exceeding timelines.
- Familiarity with AMA Style guide and an understanding of clinical research principles and applied statistics. Familiarity with ICMJE, GPP, and other medical publishing guidelines (PRISMA, STROBE, CONSORT, etc.).
- Proficient editing skills and expertise in Microsoft Office, Acrobat and other applications.
- Experience conducting literature searches and working with PMQ tools such as PubMed, Ovid, Embase.
- Experience working with reference management and citation software (EndNote, Mendeley, Citavi).
- Strong understanding of regulatory requirements and best practices in relation to Medical Information, Medical Affairs and promotional and non‑promotional material review.
- Excellent project‑management skills and proven track record of being results‑driven; ability to manage.
- Ability to conceptualize, design and deliver best‑in‑class solutions.
- Highly principled – 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.
PREFERRED QUALIFICATIONS
- Experience developing medical content, especially Medical Information materials, for new product launch.
- Experience publishing abstracts, posters, manuscripts.
- Experience working across multiple therapeutic areas.
- Experience working with Veeva Vault MedComms / PromoMats.
EEO STATEMENT
From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees come from a wide range of backgrounds and experiences. All individuals are evaluated on the basis of their qualifications and merit. All applicants and employees are considered for employment without regard to race, color, religion, national origin, gender, sexual orientation, age, disability status, veteran status, or any other characteristic protected by law.