Remote Senior Technical Writer, Medical Device CER/SSCP

Mykelly; Raynham (MA); A distancia; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work

Full benefits

Paid time off

401K and retirement benefits

Descripción de la vacante

Kelly Science & Clinical FSP seeks a Sr. Technical Writer for a remote opportunity supporting a Medical Device client. The role provides oversight and execution of CER and SSCP reports within Kelly FSP, a managed service provider unit.

The writer will mentor junior teammates, perform technical reviews for regulatory compliance, and collaborate across the team to meet project timelines. This full-time position offers comprehensive benefits and a flexible work arrangement.

Formación

• Experience with CER regulatory requirements, evidence generation and CER document creation.
• Strong verbal communication skills and interpersonal relationships.
• Familiarity with clinical research, quality/regulatory compliance and adverse event processes.

Responsabilidades

• Plan and write CERs and SSCPs and mentor junior technical writers.
• Conduct technical reviews to ensure accuracy and regulatory compliance.
• Collaborate with team members to address contributor needs and timelines.
• Manage daily activities to meet project timelines and deliverables.
• Participate in workshops to improve process efficiency and regulatory understanding.
• Support audits and inspections as subject matter authority when needed.

Conocimientos

CER regulatory requirements

Clinical research knowledge

Verbal communication

Interpersonal relationships

Educación

BA/BS/BSN degree

Descripción del empleo

Kelly Science & Clinical FSP seeks a Sr. Technical Writer for a remote opportunity supporting a Medical Device client. The role provides oversight and execution of CER and SSCP reports within Kelly FSP, a managed service provider unit.

The writer will mentor junior teammates, perform technical reviews for regulatory compliance, and collaborate across the team to meet project timelines. This full-time position offers comprehensive benefits and a flexible work arrangement.