Onsite Associate Manager – Medical Communication

Posted 22 minutes ago

Apply now

About the role

  • Associate Manager Medical Communication preparing clinical and regulatory documents for medical technology firm. Ensuring compliance with medical device regulatory requirements and mentoring junior staff.

Responsibilities

  • Prepares complex clinical and regulatory deliverables in accordance with internal GSOPs and applicable regulatory guidelines with minimal oversight
  • Authors clinical documentation including Literature Review Protocols and Reports, Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance, and Post-Market Clinical Follow-Up Plans and Reports
  • Develops additional deliverables such as clinical study reports, investigator brochures, manuscripts, posters, abstracts, publication plans, and internal white papers
  • Performs and documents methodologically sound literature searches and critically evaluates peer-reviewed clinical data
  • Maintains compliance with European, Australian, Canadian, and U.S. medical device regulatory requirements
  • Partners with subject matter experts and external vendors to develop technical content that meets regulatory and business needs
  • Mentors junior staff and helps develop templates, tools, SOPs, and best practices

Requirements

  • Bachelor’s degree (BA/BS) required; advanced degree (PhD or PharmD) preferred
  • Minimum of 8 years of industry experience (5 years with PhD/PharmD)
  • At least 5 years as a medical writer
  • Advanced medical writing
  • Regulatory knowledge
  • Project management
  • Strong attention to detail
  • Proficiency with MS Office and reference management tools

Benefits

  • medical
  • dental
  • vision
  • life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • savings plan (401(k))

Job title

Associate Manager – Medical Communication

Job type

Experience level

JuniorMid level

Salary

$82,000 - $113,000 per year

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job