Associate Compliance Specialist, Quality Event Management

0-5 years

Not Disclosed

10 Oct. 17, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Quality and Compliance Support Specialist

Summarized Purpose:
Supports and implements quality and compliance processes, facilitates tracking and reporting of activities, maintains tools and materials, and provides expertise to advance the department's vision.

Job Requirements:

Research and address issues using problem-solving methodologies, documenting in accordance with ALCOA principles and compliance metrics related to quality activities.
Ensure appropriate execution and completion of quality processes.
Participate in small to medium-scale process improvement initiatives.
Communicate with representatives from other departments to maintain quality and timelines for compliance activities (e.g., client audits, CAPA, and procedural documents).
Develop support materials, presentations, and tools to support departmental strategies.

Job Complexity:

Works on diverse problems with subject matter input, appropriate data management, and requires strong problem-solving skills.

Job Knowledge:

An experienced professional with a comprehensive understanding of the specialization; resolves a wide range of issues creatively.

Supervision Received:

Normally receives detailed instructions on all work.

Business Relationships:

Represents the department as a primary contact on projects, interacts with internal and external personnel on significant matters, and networks with senior collaborators in their area of expertise.

Qualifications:

Education and Experience:

Bachelor’s degree or equivalent relevant formal qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job (0 to 2 years). An equivalency of education, training, and/or related experience may also be considered.

Knowledge, Skills, and Abilities:

Effective oral and written communication skills in English.
Strong prioritization and time-management skills.
Knowledge of the clinical trial process and understanding of ICH GCP and other relevant regulations.
Demonstrated problem-solving skills, including root cause analysis and corrective/preventive actions.
Strong attention to detail and computer skills; ability to learn and use appropriate software.
Ability to prioritize tasks for efficient workload management.
Flexibility and adaptability in changing conditions.
Strong judgment, decision-making, issue, and risk management skills.
Creative and critical thinking abilities.

Management Role: No management responsibility.

Working Conditions and Environment:

Work performed from a remote home-based office environment with exposure to electrical office equipment.

Physical Requirements:

Ability to work in an upright and/or stationary position for 6-8 hours per day.
Repetitive hand movements for simple tasks.
Light to moderate lifting (15-20 lbs).
Proficient in a variety of computer software.
Effective communication skills and ability to listen and understand spoken information.
Frequent cross-functional interaction for information acquisition.
Works independently with moderate guidance, planning schedules to meet goals.
Performs a variety of tasks with changing demands and conditions.
Ability to perform under stress and multitask.
Regular and consistent attendance.

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Associate Compliance Specialist, Quality Event Management

Job Description

Job Description: Quality and Compliance Support Specialist

Job Requirements:

Job Complexity:

Job Knowledge:

Supervision Received:

Business Relationships:

Qualifications:

Working Conditions and Environment:

Physical Requirements:

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