Medical Writer

Job Title: Medical Writer

Department: Study Set Up

Location: Remote, United Kingdom

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

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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
• s.Lead the development, revision, and maintenance of lab manuals in accordance to SOPs and regulatory requirement
• 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 trial
• 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