Clinical Trials Medical Writer

Rochester Regional Health; United States; Teletrabalho; USD 77 000 - 92 000; Tempo integral

Resumo da oferta

Rochester Regional Health seeks a Medical Writer to interpret complex clinical study protocols and related medical documents, coordinating lab specifications and study-specific materials for ACM Global Laboratories. You will collaborate with internal departments to draft, review, edit, and finalise documents used to conduct clinical studies.

The role includes leading document development, liaising with stakeholders, and ensuring SOP/regulatory compliance.

Qualificações

• BA/BS, or equivalent experience in scientific field.
• 1 yrs clinical trials or other laboratory experience required.
• Applied knowledge of routine document content preparation, including 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.

Responsabilidades

• Lead the development, revision, and maintenance of complex clinical study and amendments in accordance to SOPs and regulatory requirements.
• With mentor, develop and maintain high profile and expedited complex study documents and amendments per SOPs and regulatory requirements.
• Author and finalize global lab specification documents (GLSD) and related documents as needed.
• Interpret 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 for medical documentation used 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 meets high quality standards.
• 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 QA processes.
• Review high complexity GLSD in accordance with SOPs and QA processes with mentor support.
• Lead development, revision, and maintenance of lab manuals per SOPs and regulatory requirements.
• Review lab manuals to ensure alignment with SOPs and QA processes.
• Resolve challenges and build consensus between cross-functional groups.

Conhecimentos

Excellent communication

Influence others

Team collaboration

Formação académica

BA/BS or equivalent in scientific field

1 year clinical trials or laboratory experience

Ferramentas

Microsoft Office

Desktop publishing

Descrição da oferta de emprego

Job Title: Medical Writer

Department: Study Set Up

Location: Remote | United States

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

PHYSICAL REQUIREMENTS:

S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

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:

$77,000.00 - $92,000.00

CITY:

Rochester

POSTAL CODE:

14624

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.