Medical Writer

Found in: Talent US C2 - 1 week ago

Fort Washington, United States Inizio Engage XD Full time

Inizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.

Inizio Engage is seeking a team of Medical Information Leads to create a high-quality Medical Information (MI) contract that addresses the needs of customers and ensure successful execution of MI content strategy and initiatives. The Medical Information Lead will be reporting to the Associate Business Unit Director, Contact Center Operations. The role is full remote.

  

What’s in it for you?  

  

  • Competitive compensation  

  • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and bonding time benefits, employee discounts/promotions  

  • Generous performance-driven Incentive Compensation package  

  • Competitive environment with company wide recognition, contests, and coveted awards  

  • Exceptional company culture  

  • Recognized as a Top Workplace USA 2021  

  • Awarded a “Great Place to Work” award in 2022 and 2023  

  • Fortune Best Workplaces in Biopharma 2022  

   What will you be doing?  

  • Create and review medical content for patients, HCPs and payers to ensure scientific rigour, balance and influence, this includes field medical slides (MSLs and MEDs),  and standard or complex medical information responses.      
  • Provide medical review for scientific accuracy and provide input on the development/use of scientific and promotional materials consistent with approved client processes (PRC/RDC) and in close partnership with client Medical Partners  
  • Author and review US MI responses by identifying and summarizing complex scientific literature in a scientifically accurate, fair balanced, concise and compliant manner to help inform clinical decision-making by HCPs. 
  • Plan and maintain a product response MI database including launch readiness plans that meets the scientific needs of customers     
  • Be a subject matter expert for the Therapeutic Area(s) and maintain in-depth product and therapeutic area(s) knowledge     
  • Perform ongoing literature reviews and extracts complex data from scientific literature and arrange the data in an organized format    
  • Provide clinical guidance and MI to assist the resolution of escalated medical and access inquiries from the contact center     
  • Review complex and escalated MI cases   
  • Review derivative content and ensuring understanding of MI responses and compliant with relevant approval process     
  • Track recurring queries and identify need for creation of new standard responses
  • Provide relevant team members with actionable insights based on knowledge of product/therapeutic area 
  • Maintain reference materials and data on file summaries       
  • Maintain understanding of MI contact center processes and technology 
  • Support training of contact center staff     

  

What do you need for this position?  

  • Advanced Clinical/Science Degree required (e.g. PharmD, PhD, MD)
  • 5 or more years’ relevant industry work experience or is a recognized expert in the field
  • 5 or more years’ medical communication experience
  • 2 or more years’ clinical experience or equivalent experience
  • Experience with all aspects of healthcare communications activities and has demonstrated ownership of expertise and creativity in healthcare communications
  • Experience creating compelling content disseminated via many medical affairs channels
  • Have an execution mindset with to ensure content is delivered on time and within budget
  • Superb collaboration in developing partnerships with peers
  • Adapt and iterate to meet customer needs.
  • Know how to organize activities to achieve impactful outcomes
  • Substantive understanding and exposure to corporate legal and compliance groups, and is knowledgeable of issues related to, GCP, OIG, US Regulatory/FDA requirements, drug access and other guiding or controlling elements of our business
  • Comply with all laws, regulations and procedures that govern the conduct of our client company

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