Business Analyst, Medical Affairs

2+ years

Not Disclosed

Remote, USA

10 Nov. 21, 2024

Job Description

Job Type: Full Time 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 Title: Business Analyst – GxP Validated Systems (Medical Affairs)
Company: Katalyst Healthcares & Life Sciences
Location: Remote
Contract Type: Contract

Company Overview:

Katalyst Healthcares & Life Sciences is currently hiring entry-level candidates for multiple contract research positions in Clinical Trials of drugs, biologics, and medical devices. We have several immediate openings in Drug Safety, Pharmacovigilance, and Clinical Research. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners to support the development of life-saving treatments and innovations.

Job Description:

We are seeking a Business Analyst with strong experience in managing GxP validated systems and business requirements in the Medical Affairs domain. The ideal candidate will be responsible for gathering business requirements, developing functional specifications, and ensuring seamless collaboration between stakeholders, developers, and testing teams.

Responsibilities:

Conduct interviews with business stakeholders to gather and define business requirements.
Propose solutions and finalize the scope of requirements.
Manage action items and tasks with business and IT stakeholders.
Develop User Requirement Specification (URS) and Functional Specification (FS), including use cases, data requirements, and process flow diagrams.
Collaborate with developers and test engineers to ensure the solution meets business requirements.
Work with the Validation Lead to ensure all deliverables meet recommended validation standards.
Create test cases and facilitate User Acceptance Testing (UAT) to validate the solution.
Provide support to the business during the post-implementation hyper-care phase.

Requirements:

Strong Business Analyst (BA) skills with the ability to manage ambiguous situations.
Prior experience working on GxP validated systems.
Experience in the Medical Affairs domain (e.g., Veeva, Salesforce) is preferred but not required.
Ability to work effectively with both technical and non-technical stakeholders.
Strong communication, organizational, and problem-solving skills.

Additional Information:

All your information will be kept confidential according to EEO guidelines.

Apply Now: Katalyst Healthcares Careers

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Business Analyst, Medical Affairs

Job Description

Company Overview:

Job Description:

Responsibilities:

Requirements:

Additional Information:

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