Clinical Trials Medical Writer

Job Title: Medical Writer

Department: Study Set Up

Location: Remote East Coast | Must Sit in East Coast

Hours Per Week: 40 hours

Schedule: Days, Monday – Friday

SUMMARY

The Medical Writer is responsible for interpreting complex clinical study protocols and other medical/scientific documentation to prepare and coordinate laboratory specification and study‑specific medical/technical documents for ACM Global Laboratories. They will partner with internal departments in the development, drafting, review, editing, and finalization of documents used to conduct clinical studies.

RESPONSIBILITIES

• Lead the development, revision, and maintenance of complex clinical study and amendments in accordance to standard operating procedures (SOPs) and regulatory requirements.
• With support of a mentor, work on the development, revision, and maintenance of high profile and expedited complex study documents and amendments in accordance to SOPs and regulatory requirements.
• Responsible for authoring and finalizing global lab specification documents (GLSD) and other related documents, as needed.
• 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 internal and external document review.
• Liaise and drive timely collaboration between key stakeholders to ensure technical documentation meet high quality standards and aligns with business process.
• Participate in client interactions during study start-up activities and/or during study amendment process.
• Review of low to medium complexity GLSD in accordance to SOPs and Quality Assurance processes.
• With support of a mentor, work on the review of high complexity GLSD in accordance with SOPs and Quality Assurance processes.
• Lead the development, revision, and maintenance of lab manuals in accordance to SOPs and regulatory requirements.
• Review lab manuals to ensure alignment with SOPs and Quality Assurance processes.
• Resolve challenges and build consensus between all cross-functional groups and collaborators in a timely manner.
• 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.
• Demonstrate initiative in professional self-development to improve job performance to maintain relevant working knowledge of clinical trials.
• Resolve queries for complex studies by using knowledge of regional differences and internal ACM processes for low and medium complexity GLSD and understanding of department responsibilities.
• Perform other duties and/or tasks as assigned.

REQUIRED QUALIFICATIONS

• BA/BS, or equivalent experience in scientific field
• 1 yrs clinical trials or other laboratory experience required

PREFERRED QUALIFICATIONS

• Applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, regulatory guidance documents, and templates
• Proficient in Microsoft Office and desktop publishing or word processing
• Education in medical or technical writing
• Excellent communication skills
• Ability to effectively influence others, work in a team environment, and collaborate across lines of business and functions
• 1+ years’ experience drafting clinical trials documentation

The posted pay range is a good faith representation of potential base pay for this position. It may be modified in the future and eligible for additional pay components. Individual annual salaries/hourly rates could vary based on position details and FTE. Pay is determined by considering factors including, but not limited to, experience, relevant qualifications, specialty, internal equity, locations, and contracts.