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Manager/Sr. Manager, Medical Communications

3 months ago

Irvine, United States HOYA Surgical Optics Full time

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: USA/Irvine, California


Role Overview

The main purpose of the position is to develop and execute medical communications strategies for HSO’s Global Medical Affairs. The Manager/Sr. Manager, Medical Communications is also responsible for overseeing and/or writing clinical study reports and protocols, manuscripts for peer-reviewed scientific articles, investigator 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

  • Contribute to the development and implementation of the medical affairs communication platform and strategy.
  • Manage medical writing projects including the design, planning, and preparation of manuscripts for peer-reviewed publications and medical congress abstracts, posters, and presentations (peer-reviewed publications, abstracts, presentations, and posters).
  • Lead the development of clinical documentation, trials, and sections of filings for regulatory purposes (clinical investigational plan, informed consent, clinical study report).
  • Review reports and cross-check information systematically.
  • Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
  • Assist in planning and implementation for symposiums, conferences, and peer-reviewed publications.
  • Write and/or 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.
  • Stay up to date and conduct literature review on current advances and industry trends on cataracts, cataract surgical procedures, intraocular lenses, and related devices.
  • Perform frequent and thorough quality control checks on each submissions.
  • Adhere to industry regulations and Good Publication practices.
  • Ensure that documents adhere to the organization’s writing guidelines, and are appropriately stored and organized.
  • Collaborate and verify data with the internal R&D and Clinical Affairs team.
  • Collaborate with key internal and external stakeholders to align with objectives and expectations
  • Collaborate with Corporate Communications to create content calendars and timelines for our website, newsletters, and marketing.
  • May conduct interviews with subject matter experts, IOL thought leaders and providers about medical breakthroughs.


Requirements

Experience

  • 8+ years of medical writing and medical affairs communication experience
  • 3-5 years of experience in clinical, regulatory scientific position in industry or academic setting
  • Writing clinical study reports and manuscripts for peer-reviewed publications
  • Experience using various digital tools and resources
  • Previous experience working in the field of cataract surgery devices, intraocular lenses, and Ophthalmology preferred
  • Experience in medical device regulations, ability to collaboratively work across various functions


Skills/Accreditations

  • Excellent verbal and written communication skills
  • Understanding of global clinical and regulatory requirements in the industry
  • 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
  • Project management
  • Proven ability to work in a face-paced, agile work environment


Academic Qualifications

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


Travel requirements

  • 10% to 20%


By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.


If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.