THE POSITION:
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 etc. This role is within the EVERSANA Compliance team reporting directly to the Manager, Medical Content Development. This person will also collaborate very closely with other team members with in 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. This includes companies of various sizes and, in particular, small and emerging companies. Position is responsible for content development-related client engagements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
- Plays an essential role supporting Manager, Medical Content Development on content development-related 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 related to Medical Affairs, Medical Information and Medical Communications including, but not limited to, Scientific Response Documents (SRD), Frequently Asked Question (FAQ) documents, Slide Sets, Abstracts, Posters, Education and Training materials, and others for potential clients.
- Drives the client document development process from gathering materials and developing scientifically rigorous content to facilitating document review and discussions at medical, legal, regulatory (MLR) review meetings.
- Works with EVERSANA and/or client-provided document management technology platforms (i.e., Veeva PromoMats / MedComms, etc.) as content owner when appropriate, uploading documents, providing reference anchoring and annotations as required.
- May be called up to perform scientific data fact checking for documents in support of medical reviewers participating in MLR teams.
- Collaborates with Manager, Medical Content Development and contributes to discussions on strategy, tactical execution and communication approaches for assigned projects.
- Participates in key client meetings as assigned.
- Supports preparation of thought leadership articles, newsletter, publications, congress presentations, slides, and blogs related to the medical content services and practices.
- Supports creating/updating the SOPs, checklists, templates, style guides, and guidance documents as necessary.
- Mentoring and coaching team members. Support hiring and onboarding as necessary.
- Stays knowledgeable of industry best practices and supports 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.
- 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, oversees, mentor direct reports and consultants supporting various clients
- Responsible to work collaboratively with EVERSANA medical information and medical affairs team 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/week.