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8-10 years
Not Disclosed
10 Nov. 11, 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 Title: Senior Medical Writer - IVD/Genetics/Oncology

Location: Remote
Employment Type: Contract


Company Overview:

Katalyst Healthcares & Life Sciences is hiring entry-level and experienced candidates for several contract research positions in clinical trials for drugs, biologics, and medical devices. We partner with university hospitals, pharmaceutical companies, and recruiting firms to bring innovative therapies to market.


Position Overview:

We are seeking a Senior Medical Writer with expertise in clinical validation plans, clinical study reports (CSRs), protocols, manuscripts, and other regulatory and medico-marketing documents, with a focus on In-vitro Devices (IVD), Genetics, and Oncology domains. This role also requires project management experience and knowledge of regulatory and audit requirements for IVDs.


Key Responsibilities:

  • Medical Writing: Develop and write clinical validation plans, protocols, clinical study reports (CSRs), manuscripts, and other regulatory documents for IVDs, genetics, and oncology studies.
  • Project Management: Lead medical writing projects and ensure the completion of documentation according to specified timelines and regulatory standards.
  • Document Management: Work with templates, style guides, SharePoint, and document management tools to ensure the accuracy and consistency of all written deliverables.
  • Regulatory Compliance: Understand and implement regulatory requirements for IVDs, including audit standards and Good Clinical Practice (GCP) guidelines.
  • Collaboration: Coordinate with cross-functional teams, including clinical research teams and external stakeholders, to ensure timely completion and quality of medical writing deliverables.

Qualifications & Skills:

  • Education:
    • Bachelor's degree in Medicine, or PhD in Life Sciences.
    • Master’s degree in Biomedical Sciences or related fields is preferred.
  • Experience:
    • 8-10 years of experience in medical writing or related domain, with a strong focus on clinical validation plans, protocols, CSRs, and regulatory/medico-marketing documents.
    • Extensive experience in the IVD, Genetics, and Oncology domains.
    • Proven experience in project management in the medical writing field.
  • Skills:
    • Expertise in MS Word, MS PowerPoint, MS Excel.
    • Experience with templates, style guides, and document management tools such as SharePoint.
    • Solid understanding of Good Clinical Practice (GCP) and regulatory requirements for IVDs.
    • Excellent written and spoken English communication skills.

Additional Information:

All personal information will be kept confidential in accordance with EEO guidelines.