Expert Writer, Medical Content Development

1 week ago

Pune, India EVERSANA Full time

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


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

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