Clinical Trials Medical Writer

## Clinical Trials Medical Writer Apply:
ACM - Remote:
Full time:
Posted Today:
REQ _243982
*
* 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
*
* EDUCATION:

**** LICENSES /

CERTIFICATIONS:

***
* PHYSICAL REQUIREMENTS:

** Sedentary -…