Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.

Our Client a fast-growing global pharmaceutical company that that focus on drug discovery, product development, and commercialization is seeking a Medical writer to serve as the primary writer on projects and documents. This is a hands-on, individual contributor, writing position. The incumbent will be required to work flexibly across a number of clinical stage projects, providing clinical regulatory writing support to various functions and projects through writing, editing, and reviewing clinically focused documents. This includes but is not limited to: Investigator Brochures, Clinical Protocols, Clinical Study Reports, Safety Narratives, and Lay Summaries.

Prepare, edit, and review clinical documents including, but not limited to: Investigator Brochures, Clinical Protocols, and Clinical Study Reports:

• Ensure that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messages, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• Take ownership of a given assignment providing high level clinical regulatory writing support and serve as coordinator for document workflows.
• Critically evaluate, review, and interpret clinical data and medical literature.
• Proactively consult with other team members and department representatives for information or guidance as necessary.
• Perform data review, analysis activities, and quality control checks relevant to document type. Identify and resolve errors and inconsistencies in clinical data with project team members.
• Drive compliance with document creation SOPs and documents governing content.
• Suggest common ways of working and standards across projects and sites, establishing the role of medical writer as a fully integrated function on international study teams.
• Participate/recommend preparation/revision of document templates, development of processes (preparation/revision of SOPs) or other documents guiding content.
• Participate significantly in meetings at the study level.
• Work successfully with a medium level of direct supervision.
• Establishes clear and regular communication plan with line manager.
• Other duties as assigned by Associate Director and Director, Medical Writing commensurate with role.
  

REQUIREMENTS

• PhD (in a scientific, medical, or clinical discipline), PharmD, MD (or equivalent) with at least 3+ years of regulatory medical writing experience for a pharmaceutical company or contract research organization (CRO), and an understanding of clinical regulatory documentation requirements would be preferred.
• High-level writing and editing skills demonstrating a strong understanding of clinical data and the ability to organize and present information.
• Understanding of all phases of the drug development process and the interdependencies between drug development and other functional areas.
• Knowledge and understanding of ICH-GCP and experience as lead-writer for study related documents.
• Excellent English, both written and spoken.
• **Note: Candidates may be asked to provide original writing sample to support/assess scientific writing ability and style in the English language, and/or ability to independently analyze/present data.
• Must be proficient with Microsoft Office applications, use of relevant software applications, using templates, and other electronic formats and systems.