Expert Writer, Medical Content Development

Job description

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, 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. EXPECT AT IONS 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. Qualifications 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), PhD, or MD 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 Medical Information / Medical Communications / Scientific Communications experience Exceptional communication skills including, written, oral, interpersonal, and presentation skills including 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 as well as an understanding of clinical research principles and applied statistics. Familiarity with International Committee of Medical Journal Editors (ICMJE), Good Publication Practices (GPP), and other medical publishing guidelines (e.g., Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), Consolidated Standards of Reporting Trials (CONSORT), etc. Proficient editing skills along with expertise in Microsoft Office, Acrobat and other applications. Experience conducting literature searches and working with tools such as PubMed, Ovid, Embase, etc. Experience working with reference management and citation software (e.g., EndNote, Mendeley, Citavi, etc.) Strong understanding of regulatory requirements and best practices in relationship to 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 Ability to conceptualize, design and deliver best in class solutions 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 functionality 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 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