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Job Title: Clinical Trials Technical Writer
Department: Study Set Up
Location: Remote, United Kingdom
Hours Per Week: 40 hours
Schedule: Days; Monday – Friday
SUMMARY
The Clinical Trials Technical Writer is responsible for interpreting complex clinical study protocols and other medical/scientific documentation. Prepare and coordinate laboratory specification and study specific medical/ technical documents for ACM Global Laboratories. With team mentor support, this position will partner with internal departments in the development, drafting, review, editing and finalization of documents use to conduct clinical studies
.
RESPONSIBILITIE
- S Lead the development, revision and maintenance of low complexity study documents in accordance to SOP's and regulatory requiremen
- tsWith support from team mentor, work on the development, revision and maintenance of medium to high complexity study documents in accordance to Standard Operating Procedures (SOP) and regulatory requiremen
- tsResponsible for authoring and finalizing Global Lab Specification Documents (GLSD)and other related documents, as need
- edSupport the review of low to medium complexity GLSD in accordance to SOP's and Quality Assurance process
- esLead the development, revision and maintenance of lab manuals in accordance to SOP's and regulatory requiremen
- tsReview lab manuals to ensure alignment with SOP's and Quality Assurance process
- esWith support from team mentor, interpret the scientific details of the protocol/technical documents and identify and resolve gaps to ensure client satisfacti
- onLead, initiate and manage multiple rounds of internal & external document revi
- ewLiaise and drive timely collaboration between key stakeholders to ensure technical documents meet high quality standards and align with business proces
- s.Resolve challenges and build consensus between cross‑functional groups and collaborators in a timely manne
- r.Participate in client interactions during study start-up activities and/or during study amendment process related to the technical documentation with support of assigned team mento
- r.Demonstrate initiative in professional self-development to improve job performance to maintain relevant working knowledge of clinical trial
- s.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 regulation
- s.Perform other duties as assign
ed
REQUIRED QUALIFICATI
- ONSBachelor's degree or equivalent experience in scientific fi
eld
PREFERRED QUALIFICAT
- IONSApplied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, regulatory guidance documents, and templa
- tes.Proficient in Microsoft Office and desktop publishing or word proces
- singEducation in medical or technical wri
- tingExcellent communication sk
- illsAbility to effectively influence others, work in a team environment, and collaborate across lines of business and functi
ons.
