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Job Openings

Sr. / Medical Writer

Role
Clinical Trial Management
Location

Irvine

USA
Job Description

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

 

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

 

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

 

HSO way of working

 

In fulfilling our roles, we are

  • Accountable for our own capabilities and development,
  • Focused on delivering results without excuses, and
  • Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

 

We are looking for people who

  • See beyond themselves and are impact-focused,
  • Consider the needs, challenges, and objectives of every person with whom they interact, and
  • Exhibit positive reinforcement to help others succeed.

 

About the role

Works closely with and have impact on: Clinical Affairs, R&D, Marketing

Reports to: VP, Global Medical Affairs

Function: Global Medical Affairs

Work Location/Site: California/Irvine. Remote working can be explored

 

Role Overview

The main purpose of the position is to manage, author, and review budget-assigned clinically relevant documents. The Medical Writer is responsible for writing clinical study reports and protocols, manuscripts for peer-reviewed scientific articles, brochures, and product manuals for the organization. These materials will cover topics in clinical trials, procedures, medical devices, medical research/breakthroughs, clinical data, and medical education.

 

Duties and Responsibilities

  • Lead the development of clinically relevant documents for regulatory purposes (clinical study reports, protocols, informed consent) and publications and presentations (peer-reviewed publications, abstracts, presentations, and posters)
  • Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation
  • Manage medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings
  • Write and edit high-quality manuscripts for medical journals, abstracts, white papers, articles, brochures, regulatory documents, and product manuals about cataract, IOL or related topics such as new medicinal discoveries/treatments, educational materials, clinical research, and product instructions
  • Conduct literature review that are in tune with current industry trends on cataracts, cataract surgical procedures, intraocular lenses, and related devices
  • Collaborate with the Communications Team to create content calendars and timelines for our website, newsletters, and marketing
  • Conduct interviews with subject matter experts, IOL thought leaders and providers about medical breakthroughs
  • Collaborate and verify data with the internal R&D and Clinical Affairs team
  • Systematically review reports and cross-check information
  • Execute frequent and thorough quality control checks on each submissions
  • Ensure that documents adhere to the organization’s writing guidelines, and are appropriately stored and organized.

 

Requirements

 

Experience

  • At least 8 years of medical writing experience
  • 3-5 years of experience in clinical, regulatory scientific position in industry or academic setting
  • Previous experience working in the field of cataract surgery devices, intraocular lenses, and Ophthalmology preferred
  • Writing clinical study reports and manuscripts for peer-reviewed publications

 

Skills/Accreditations

  • Advanced medical and scientific writing skills
  • Ability to assess information critically and systematically
  • Ability to combine and translate complex clinical and technical information from different sources in a simple manner in oral and written form
  • Ability to thoroughly understand clinical data analysis and study designs concepts
  • Experience in medical device regulations, ability to collaboratively work across various functions

 

Academic Qualifications

  • Higher scientific education in Medicine and/or related sciences (preferably Masters / OD/ PhD/ MD level).
  • Background in Ophthalmology is preferred.

 

Travel requirements

  • Up to 10%

By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. For more information about the processing of your personal data, please refer to our Privacy Policy, which can be found here.

 

We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.

 

 

Apply Now or E-Mail your resume to hso-ghq-hr@hoya.com; subject “Application for 'Job Title'”. Thank you!