[Hiring] Medical Writer 2 @Iconma Portal

Role Description

  • Authoring sections of Clinical documentation as part of the Clinical Evaluation Reports (CER).
  • Acquire knowledge of therapeutic areas, literature review processes and the ability to keep abreast of current literature.
  • Participates in and/or performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.
  • Work with the clinical librarian to help with conducting literature searches on products/product families.
  • Review the scientific literature and critically appraise and write clinical summaries for products and surgical procedures.
  • Support the internal team members by adhering to CER timelines and providing data in a timely manner to support global Regulatory activities.
  • Interact with internal teams to understand the plan and strategy for development of the Clinical evaluation reports for new and existing products.
  • Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities.
  • May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on Client clinical trials.
  • May author Protocols and/or routine Clinical Study Progress Reports.
  • Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines).

Qualifications

  • Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports.
  • Must have a minimum of 2-4 years of medical writing experience.
  • Minimum of 0-2 years of experience in clinical evaluation report writing in a medical device industry is preferred.
  • Strong experience in conducting literature searches, reviews and appraisal of the scientific data.
  • Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills.
  • Excellent critical and analytical thinking skills.
  • MD, PhD or M.S. degree in scientific field is desired.
  • Must have high level of attention to detail and accuracy.
  • Must be able to work effectively with internal team members.
  • Must be able to manage multiple projects across numerous surgical disciplines.
  • Strong communication, presentation and interpersonal skills with high attention to detail and organization.
  • Strong experience in protocol development and writing clinical section for regulatory submission.
  • Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude).
  • Consistently shows dedication or strong work ethic to help meet aggressive timelines or multiple projects when necessary.

Benefits

  • Health Benefits
  • Referral Program
  • Excellent growth and advancement opportunities
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