Medical Writer

#usa

#copywriting

#full-time

Position Summary: 

The Medical Writer will develop, create, edit, and coordinate the production of image review charters, reader manuals, technical operations manuals, clinical study protocols, and other critical study or company documents that may or may not be associated with submission to a regulatory agency. This role includes the contribution to a library of reusable text and templates based on therapeutic area, analysis methods and other relevant criteria.  In addition, this role will support the development of templates of imaging documents as requested by operations leadership.

Scope & Impact:

This position works with internal project teams and external stakeholders to develop the necessary language to support the development of charters, reader manuals and imaging operations templates to meet the required project timelines.

Major Responsibilities:

  • Author Imaging Charters and Methodology documents based on details pulled from the study protocol and in collaboration with sponsor teams based on regulatory guidelines document with respect to content
  • Author Reader Manuals to support the reader training process based on imaging charter, analysis eCRF and visualization software being used
  • Author clinical study protocols, final Study Reports if applicable
  • Develop imaging document templates as required by operational leadership to create efficiencies and development of standard look and feel across documents
  • Support content development of a standard library of reusable templates and text to create efficiencies in document authoring
  • Provide input to Standard Operating Procedures and Work Instruction Documents for the Medical Writing group as necessary
  • Coordinate sign-off of document deliverables according to appropriate SOPs\WIDs, including pre-execution activities such as distributing drafts for review, addressing questions, chairing round table meetings, and incorporating revisions
  • Perform quality control review such as copy editing, content editing, and number checking for other writers as necessary
  • Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents
  • Attend internal technical team and client team meetings as required
  • Serve as Medical Writing representative on assigned Project teams
  • Regularly communicate project related issues with Medical and Scientific teams and the project team, as appropriate

Qualifications: 

  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
  • Medical/technical writing experience of at least 2 years in a clinical research setting
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
  • Able to work independently
  • Attention to detail and ability to multitask
  • Strong written and oral communications skills, as well as excellent interpersonal and negotiation skills
  • Strong word processing skills including familiarity with MS Office products for documentation and presentation development

What We Offer:

  • Competitive salary
  • 401k with generous matching
  • Insurance Plans
  • Flexible vacation policy
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.
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