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

EDUCATION:

LICENSES / CERTIFICATIONS: 

PHYSICAL REQUIREMENTS:

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

CITY:

POSTAL CODE:

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.