Senior Medical Writer — Clinical Evidence (Remote)

Stryker; Fremont (CA); Remote; USD 110,000 - 238,000; Full time

Job summary

Stryker is seeking a Senior Staff Medical Writer in the Neurovascular Division for a remote position in the United States. You will lead the development of clinical evidence strategies and scientific documentation to support regulatory submissions, market access initiatives, and product lifecycle decisions.

The role partners with Regulatory Affairs, R&D, Clinical, Marketing, and Quality to ensure evidence is effectively evaluated, communicated, and applied across the product lifecycle.

Qualifications

• Master's degree in a health or science field required.
• 6+ years in clinical affairs, regulatory, quality, medical writing, or related field.

Responsibilities

• Lead the development and execution of clinical evidence strategies for product development and lifecycle management.
• Manage clinical evaluation projects aligning clinical evidence with regulatory strategy and commercialization objectives.
• Author and maintain clinical evaluations, post-market documentation, regulatory submissions, and annual reports.
• Design and execute systematic literature reviews, evaluate evidence, and synthesize data into supported conclusions.
• Assess benefit-risk profiles and develop evidence-based recommendations per global regulatory requirements.
• Partner with regulatory authorities and internal stakeholders to address clinical evidence requirements for submissions.
• Develop scientific communications including manuscripts, abstracts, presentations, and customer-facing materials.
• Mentor team members and improve evaluation methodologies and processes.

Skills

Medical writing

Regulatory affairs

Clinical evaluation

Evidence synthesis

Education

Master of Science degree in a health/science field

Doctoral degree (PhD, PharmD, MD)

Job description

Stryker is seeking a Senior Staff Medical Writer in the Neurovascular Division for a remote position in the United States. You will lead the development of clinical evidence strategies and scientific documentation to support regulatory submissions, market access initiatives, and product lifecycle decisions.

The role partners with Regulatory Affairs, R&D, Clinical, Marketing, and Quality to ensure evidence is effectively evaluated, communicated, and applied across the product lifecycle.