Medical Writer

TSR Consulting Services provides best in class staffing solutions to clients nationwide, by staying true to our relentless focus of exceeding the highest professional IT service business standards. Today, as a NASDAQ company specializing in IT consulting and staff augmentation, TSR continues to expand and transform its services to meet and anticipate its client’s and candidate’s’ needs. For more than 53 years, TSR's has been a leader in the industry because of our expertise and knowledge of the job market, our compassion and caring of our clients and consultants and our work environment of respect and inclusion. Your career is in good hands with TSR because at the end of the day, if YOU THRIVE, WE THRIVE.

Our client, a leading Pharmaceutical company is hiring a Medical Writer on a  contracting basis.

Work Location: Princeton NJ

Summary:

• Develop and update worldwide medical content (standard responses, slide decks, training modules, Q&As, etc) per clinical development program, publications, data presentations, congress activity, inquiry trends, global communication platform, product safety reports, and treatment landscape
• Provide literature searches, medical writing, and data accuracy review for medical content
• Literature search: identify and review all relevant data through literature search to ensure clear understanding of data and articulate data required in medical content deliverables
• Medical writing: write concise medical standard responses in to the format to ensure succinct, factually relevant responses available for customer
• Data Accuracy review: perform data accuracy review to verify all data used is correct and supported by appropriate reputable references
• Maintenance of content trackers
• Support the identification of medical content for update
• Participate in strategic development sessions
• Help develop Medical Contact Center training on disease state, product overviews, and relevant market events to ensure Contact Center’s readiness to address customer inquiries
• Consistently maintain in-depth knowledge of relevant therapy areas, products, and objectives
   

Required skills:
 

• MPharm, PhD, or life sciences degree with a preferred minimum of 2 years experience in medical writing and editing in medical communications, medical education, or medical information
• Experience in Immunology/Rheumatology therapy areas preferred
• Strong scientific/medical writing skills evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals
• In-depth knowledge of Good Clinical Practices, FDA regulations, GPP2 guidelines, and the drug development process
• Exposure to the pharmaceutical and healthcare industry with good understanding of global pharmaceutical drug development requirements for submission, basic knowledge of document publishing process, and navigating data-on-file documents, clinical study reports, investigator brochures, publications, congress materials, etc.
• General understanding of diseases and medical information requirements
• Familiarity with data sources (e.g. Journals, clinical study reports, product labels, regulatory and other websites)
• Understanding of the benefits and limitations of different data sources