STATUS: Full-Time

LOCATION: Rochester, NY

DEPARTMENT:

SCHEDULE: Monday - Friday

ATTRIBUTES

• Applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
  
  • Proficiency with desktop publishing, word processing, and/or on-line documentation software.
  • Coursework in medical or technical writing.
  • Excellent written communication skills.
  • Able to effectively influence others, work in a team environment, and to collaborate across lines of business and functions

RESPONSIBILITIES

• Lead the development, revision and maintenance of complex clinical study protocols, clinical study reports, and other medical/technical documents; responsible for authoring and finalizing documentation.
• Interpret, understand and contribute to the scientific details of the protocol/technical documentation; identify and resolve gaps to ensure client satisfaction.
• Serve as a subject-matter expert (SME) for medical documentation utilized throughout the study lifecycle.
• Lead, initiate and manage multiple rounds of document review.
• Liaise and drive timely collaboration between key stakeholders to ensure technical documentation meet high quality standards and aligns with business process.
• Lead client interactions in support of medical/technical documentation associated with studies.
• Participate in client interactions during study start-up activities and/or during study amendment process.
• Resolve challenges and build consensus between all cross-functional groups and collaborators in a timely manner.
• Ensure high quality documentation that meets regulatory requirements; proofread and copy-edit content as needed.
• Identify, develop and execute continuous improvement projects associated with technical documentation; leverage industry standards to drive best in class technical documentation.
• Maintain a general working knowledge of Food & Drug Administration (FDA), Medical & Healthcare Regulatory Agency (MHRA), New York State Department of Health (NYSDOH), Good Clinical Practice (GCP), ICH and other pertinent regulations.
• Participate in process improvement by developing methods to improve productivity, service, quality, cost savings, policies & procedures.
• Participates in Clinical Trial Study Management meetings and task forces to develop standardization in the set up process across protocols and departments.
• Demonstrate initiative in professional self-development to improve job performance to maintain relevant working knowledge of Clinical Trials.
• Aid in the development of Standard Operating Procedures and associated training.
• Manage ad-hoc process improvement/remediation projects as required Perform other duties as assigned.
• Perform other duties and/or tasks as assigned.