Medical Writer

Experis Technology Group; Santa Clara (CA); Presencial; USD 70.000 - 95.000; Jornada completa

Descripción de la vacante

ManpowerGroup’s client, a leader in medical device innovation, seeks a Medical Writer IV to join the Regulatory Clinical Evaluation team in Santa Clara, CA. The role focuses on authoring Clinical Evaluation Plans/Reports and related documents across the product life cycle.

Responsibilities include evaluating clinical evidence from investigations and literature, ensuring quality and regulatory alignment (ISO13485, MDR, EU/FDA guidance), and collaborating with cross-functional partners.

Formación

• 6–8 years of medical writing experience in medical devices or pharmaceutical industry.
• Experience with clinical investigations, literature reviews, post-market surveillance, or PMCF writing.
• Strong written and verbal communication skills with cross-functional collaboration.

Responsabilidades

• Write and contribute to Clinical Evaluation Plans and Reports (CEP/CER) and related documentation.
• Evaluate and summarize clinical evidence from investigations, literature, PMS, and PMCF.
• Ensure alignment across documents (IFUs, risk files, PMS plans, SSCPs) and regulatory compliance.

Conocimientos

Medical writing

Clinical evaluation

Regulatory knowledge

Cross-functional collaboration

Documentation quality

Educación

Bachelor’s Degree in Life Sciences

Herramientas

Word

Excel

PowerPoint

Outlook

Descripción del empleo

Our client, a leader in medical device innovation, is seeking a Medical Writer IV to join their Regulatory Clinical Evaluation team. As a Medical Writer IV, you will support the authoring of Clinical Evaluation Reporting documents for Vascular medical devices across the product development and life cycle process. The ideal candidate will bring strong technical writing skills, the ability to analyze complex clinical evidence, and a collaborative mindset to partner across cross-functional teams.

Job Title

Medical Writer IV

Location

On site at Santa Clara, CA; St. Paul, MN; Maple Grove, MN; or Plano, TX

Duration

12 months contract with possible extension

Pay Range

$60/hr w2

What's the Job?

Write and contribute to Clinical Evaluation Reporting deliverables, including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses, and related documentation. Evaluate and summarize clinical evidence from sources such as clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations; analyze results to support product applications and submissions. Collaborate with stakeholders to plan for and support CER-related projects, processes, and deliverables. Review and ensure alignment across key documents including IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), PMS Plans, PMCF Plans/Reports, SSCPs, and physician training materials. Ensure quality and compliance of deliverables by maintaining attention to detail, consistency, and data integrity while following applicable corporate/divisional policies and regulatory requirements (including ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU/FDA guidance) and Abbott SOPs/DOPs.

What's Needed?

Bachelor’s Degree or an equivalent combination of education and work experience. 6-8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience. Experience that may include medical/pharmaceutical/medical device writing, clinical research, medical or research industry writing, or a combination of these skills. Strong written and verbal communication skills, with the ability to collaborate effectively across cross-functional teams. Proficiency with Word, Excel, PowerPoint, and Outlook, plus strong analytical skills and the ability to manage complex tasks and time effectively.

What's in it for me?

Opportunity to contribute to high-impact regulatory clinical evaluation deliverables for Vascular medical devices. Work within a Regulatory Clinical Evaluation team where technical and strategic writing directly supports product development and life cycle activities. Engage with cross-functional partners across Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management, and Medical Affairs. Build and apply expertise in clinical evidence evaluation, risk alignment, and regulatory submission documentation. Start ASAP after screenings have cleared, with a Mon-Fri daytime schedule totaling 40 hours per week.

Benefits

Upon completion of waiting period consultants are eligible for: Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account Health Flexible Spending Account Dependent Care Flexible Spending Account Supplemental Life Insurance Short Term and Long Term Disability Insurance Business Travel Insurance 401(k), Plus Match Weekly Pay.

Company Culture

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells. ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.