Clinical Trials Medical Writer

Rochester Regional Health

4d•$77,000 - $92,000•Remote

About The Position

The Medical Writer, within the Study Set Up department, interprets complex clinical study protocols and other medical and scientific documentation to prepare and coordinate laboratory specifications and study-specific medical and technical documents for ACM Global Laboratories. The role partners with internal departments to develop, draft, review, edit, and finalize documents used to conduct clinical studies. The position is remote for candidates located on the East Coast and is scheduled for 40 hours per week, Monday through Friday during the day.

Requirements

BA/BS degree or equivalent experience in a scientific field.
At least 1 year of clinical trials or other laboratory experience.
Excellent communication skills.
Ability to influence others effectively, work in a team environment, and collaborate across lines of business and functions.

Nice To Haves

Applied knowledge of routine document content preparation, including style guides, medical dictionaries, regulatory guidance documents, and templates.
Proficiency in Microsoft Office and desktop publishing or word processing.
Education in medical or technical writing.
At least 1 year of experience drafting clinical trials documentation.

Responsibilities

Lead the development, revision, and maintenance of complex clinical study documents and amendments in accordance with standard operating procedures (SOPs) and regulatory requirements.
With mentor support, develop, revise, and maintain high-profile and expedited complex study documents and amendments in accordance with SOPs and regulatory requirements.
Author and finalize global lab specification documents (GLSDs) and related documents as needed.
Interpret and contribute to the scientific details of protocols and technical documentation, identifying and resolving gaps to ensure client satisfaction.
Serve as a subject-matter expert for medical documentation used throughout the study lifecycle.
Lead, initiate, and manage multiple rounds of internal and external document review.
Coordinate timely collaboration between stakeholders to ensure technical documentation meets quality standards and aligns with business processes.
Participate in client interactions during study start-up activities and/or study amendments.
Review low- to medium-complexity GLSDs in accordance with SOPs and Quality Assurance processes.
With mentor support, review high-complexity GLSDs in accordance with SOPs and Quality Assurance processes.
Lead the development, revision, and maintenance of lab manuals in accordance with SOPs and regulatory requirements.
Review lab manuals for alignment with SOPs and Quality Assurance processes.
Resolve challenges and build consensus among cross-functional groups and collaborators in a timely manner.
Maintain general working knowledge of FDA, MHRA, NYSDOH, GCP, ICH, and other pertinent regulations.
Pursue professional self-development to improve job performance and maintain relevant clinical trials knowledge.
Resolve queries for complex studies using knowledge of regional differences and internal ACM processes for low- and medium-complexity GLSDs, and understanding of department responsibilities.
Perform other duties and/or tasks as assigned.