Medical Writer II
Job Title: Medical Writer II
Location: Santa Clara, CA – Hybrid (possibly remote after onsite training) – local candidates only
Period: 08/23/2024 to 07/31/2025 – potential for extension
Hours/Week: 40 hours (Hours over 40 will be paid at Time and a Half)
Rate: $45 – $50/hour
Contract Type: W-2 only
Scope of Services:
The Medical Writer II provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to authoring Clinical Evaluation Reporting documents for the Structural Heart and Vascular products. Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed. The resource will be working within the Cardiovascular and Structural Heart areas doing clinical evaluations, plans, reports, summaries of safety and clinical performances. This job is focused on regulatory EUMDR. The Medical Writer will support regulatory activities and will NOT be doing pamphlets, brochures, etc.
Role, Responsibilities, and Deliverables:
- Writes and contributes to Clinical Evaluation reporting deliverables such as Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
- Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.
- Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
- Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
- Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.
- Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
- Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
- Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries.
- Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable SOPs and DOPs.
Experience:
- Bachelor’s Degree is required along with the 4 to 6 years of experience.
- People with clinical experience, 4 to 6 years of experience in this area or clinical studies and report writing within the Medical Device area.
- Ability to work independently after initial onboarding.
- Ability to work with teams of people in a teamwork setting with Project Managers, and the business to create documents that are fairly large in volume.
- Writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills
- CER writing experience required
Skills:
- Biomedical, sciences, medicine or similar health related discipline preferred
- Excellent written and verbal communication skills
- Experience with collaborative, cross-functional teams.
- Excellent analytical skills and ability to manage complex tasks and manage time effectively
- Proficient with Word, Excel, PowerPoint, Outlook, etc. Experience working within a Matrix Organization and Cross-Functional Teams
- Project Management experience where they owned their own projects and supported multiple technical projects
- MS Excel - Intermediate Level as they will leverage this as a tool to manage projects, data extracting, and screening, Word, and Technical Knowledge
- Citation Management Systems experience - they use Endnote but can come with other systems knowledge and experience and will train on theirs.
- Will work from a cubicle and/or remote from home if approved.