Medical Writer (R1127870)
Job Description IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. As a Medical Writer you will prepare, or contribute to the preparation of clinical documents, for either internal customers or external clients, for investigation drugs, biological, or medical devices.
You will collaborate with internal experts and specialists; conducts thorough research; maintains expertise on developments in a particular field of focus. The successful candidate will have excellent attention and accuracy with details, strong individual initiative, organizing skills and commitment to quality. They will also have the ability to establish and maintain effective working relationships with co-workers, managers and clients.
Various ANZ locations can be considered for this role. Responsibilities: Develops and manages specific short-and-long term medical writing objectives. Researches, writes and edits: clinical research protocols, informed consent forms, Investigation New Drug (INDs) applications, and clinical study reports.
Researches, writes and edits NCI CTEP clinical research protocols and informed consent forms within Operational Efficiency Working Group (OEWG) timelines. Assists physicians in clinical protocol development and keeps abreast of professional and technological advances. Develops protocol templates for studies to be conducted.
Protocol templates will contain all sections and language required by the Rutgers/RWJMS Institutional Review Board. Assists in the development of formats and guidelines for clinical documentation. Liaises with Office of Human Research Services (OHRS) and other research administration staff to facilitate submission of protocols to the CINJ Scientific Review Board (SRB) and to the Rutgers University Institutional Review Board (IRB).
Assists PIs and research staff with making necessary amendments to obtain protocol approval. Assists faculty and staff in creating appropriate publications, which may include protocol information summaries, protocol status reports, brochures, etc. in accordance with specific budgetary requirements and the Cancer Institute of New Jersey policies.
Key requirements: Bachelor's degree in Life Sciences (preferably in Pharmacy or pharmacology) Equivalent experience, education and/or training may be substituted for the education requirements. Must be well organized, be able to meet tight deadlines, be detail-oriented and a team player. Must have the ability to be flexible and work independently.
Must have the ability to communicate inter personally, to track information, to communicate visually or graphically. The individual must demonstrate the ability to handle multiple prioritie....