Randstad Medical Writing in Princeton, New Jersey
Thursday, September 29, 2016
Randstad Life Sciences
Job Title: Medical Writer/Communication Specialist
Analyzes and interprets scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance s and BMS policies and procedures, and are used to appropriately respond to inquiries from payers and Health Care Providers.
Extensive, proven experience and skill in writing high-quality, evidence-based scientific documents
Responsible for but not limited to: developing, editing and managing the production of AMCP Dossiers and scientific presentations for payers; developing and/or editing responses to address specific unsolicited payer and Health Care Provider requests for health outcome information.
Manages and prioritizes multiple projects, provides solutions to complex problems, and delivers complete and accurate information within deadlines.
Evaluates and contributes to Medical Information processes for responding to unsolicited inquiries and trains internal customers (e.g. Field HEOR) on appropriate use of these processes.
Provides medical review for the approval of medical/health economics and outcomes research materials, and ensures appropriate use of data and team compliance.
Maintains awareness of current industry practices that pertain to Medical Information
Complies with the reporting of adverse effects and product complaints to BMS Worldwide Safety and Surveillance.
PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents.
3-5 years relevant industry work experience; recognized expert in medical communications and medical writing; Oncology experience preferred Ability to write in a clear, concise, and persuasive manner
Highly proficient in the use of Microsoft WORD and POWERPOINT
Proficient in managed care or access; previous experience in formulary or evidence-based evidence writing, review and assessments, and knowledge in evidence-based healthcare decision-making processes
HEOR technical training is a plus
Knowledge of BMS products and related disease states; clinical/health economics and outcomes knowledge; capable of expert coverage across multiple therapeutic areas
Understanding of model documents (templates) and how to use them correctly
Experience in the development of AMCP dossiers and documents related to outcomes research
Knowledge of the field of medical information, including the applicable legal, regulatory and compliance framework surrounding the communication of medical information and health economics information
Knowledge of management information systems, databases and digital application of information
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance