Job Description

Job Title: Clinical Evaluation Reporting Specialist

Location: Remote

Type: Contract

Rate: $40-45/hour 

Job Description:

We are seeking a highly skilled and experienced Clinical Evaluation Reporting Specialist with a strong background in clinical research, regulatory guidelines, and medical writing. The ideal candidate will have at least five years of experience in clinical evaluation reporting, systematic literature reviews (SLRs), and clinical data appraisal within the medical device or pharmaceutical industry. This remote position offers the opportunity to contribute to the development and updating of Clinical Evaluation Reports (CERs) for company products, working closely with cross-functional teams and stakeholders.

Key Responsibilities:

1. Clinical Evaluation Reporting (CER) Development:

   • Lead the creation of Clinical Evaluation Reports (CERs) by collaborating with stakeholders across Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, Research Scientists, Pre-clinical Research Scientists, Marketing, Product Lifecycle Engineers, and information specialists.
   • Collaborate with information specialists to perform systematic literature searches on company products, equivalent products, and competitors, ensuring relevant documentation is identified for inclusion in CERs.
   • Author first drafts of SLRs, CER assessments, new CERs, and scheduled updates, prioritizing business and research needs.
   • Compile and analyze various product-related data (e.g., FMEA, RMR, PMSR, PRR, verification and validation reports, product complaints, and clinical investigation protocols).

2. Systematic Literature Review (SLR) and Data Analysis:

   • Conduct systematic literature searches on company products and related product families, including identifying relevant publications for safety and performance evaluation.
   • Review and appraise published literature to ensure it aligns with regulatory requirements and contributes to the CER development process.
   • Perform comprehensive searches related to adverse event reporting, product recalls, and compile clinical and preclinical data for clinical investigations.

3. Cross-Functional Collaboration and Regulatory Compliance:

   • Work closely with cross-functional teams, including Clinical Research Scientists and Pre-clinical Scientists, to support the development of risk management deliverables, clinical research, and literature evidence in product development processes.
   • Stay up-to-date with Clinical Evaluation Report regulatory requirements for all applicable countries and ensure compliance with relevant standards, laws, and business practices.
   • Manage document reviews, reconcile review comments, and finalize CERs for approval.

4. Training and Process Improvement:

   • Assist with the training of contractors on the development of Clinical Evaluation Reports and provide guidance on updating and refining CERs.
   • Develop policies and procedures for Clinical Evaluation Reports and systematic literature reviews, as necessary, to ensure standardization and efficiency.
   • Oversee the logistics of CER and SLR deliverables, timelines, and reviews.

5. Reporting and Documentation:

   • Maintain accurate and up-to-date records of all CER and SLR activities and ensure proper documentation is prepared for review and regulatory submissions.
   • Develop and disseminate findings from the update process of CERs, ensuring all stakeholders are informed.

Required Qualifications:

• Education: Bachelor’s degree in Life Sciences, Medical Writing, or a related field.
• Experience: Minimum of 5 years of experience in clinical research, regulatory roles, or medical writing within the medical device or pharmaceutical industry.
• Knowledge and Skills:
  • In-depth understanding of research methodology, clinical data appraisal, and regulatory guidelines.
  • Proficiency in relevant databases, such as PubMed, for literature searches.
  • Strong medical writing and editing skills, with experience in developing CERs and systematic reviews.
  • Experience in clinical evaluation reporting, clinical investigation protocols, and clinical study reports.
  • Familiarity with regulatory requirements and compliance standards across multiple countries.
  • Strong collaboration and communication skills to work effectively with cross-functional teams.

Preferred Qualifications:

• Experience in the medical device or pharmaceutical industry, specifically in clinical evaluation reporting and regulatory submissions.
• Familiarity with risk management processes, including FMEA and other risk analysis tools.

Additional Information:

• This position is remote and may require periodic interaction with cross-functional teams, contractors, and external vendors.
• Occasional travel may be required for team meetings or training purposes.

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