Irvine, CA

September 4, 2020

Location: Irvine, CA

Department: Medical Affairs

Reports To: Erin Yoder

FLSA Status: Full time

 

JOB SUMMARY: The Medical Writer will directly support the Medical and Clinical teams to produce publications in support of Agendia’s clinical trials and investigator-initiated research projects.

POSITION WITHIN THE ORGANIZATION

  1. Reports to Director of Clinical Affairs
  2. Cooperates with all departments across the organization
  3. Participates in:
  • Department meetings
  • Project meetings
  • Working groups
  • Project groups

ESSENTIAL DUTIES AND RESPONSIBILITIES: The Medical Writer will primarily be responsible for writing and or editing manuscripts for publication in peer-reviewed journals. S/he may also assist with the preparation of regulatory, reimbursement, or marketing documents. The Medical Writer will contribute to maintaining, evaluating, and summarizing literature searches for our products and for the competitive landscape.

  • Develop, write and edit scientific materials including but not limited to abstracts, posters, manuscripts, slide decks, and dossiers
  • Conduct literature searches and review of relevant information to appropriately support manuscripts
  • Manage coordination of the review process, document revisions, and submissions
  • Maintain, develop, and comply with publication procedures and SOPs
  • Assist with maintenance and organization of publications libraries
  • Assist with data abstraction, when necessary and in preparation of scientific materials
  • Assist with post-market surveillance by searching, evaluating and summarizing new literature; draft article summaries when required
  • Coordinate publications/presentations/congress events with marketing for appropriate visibility (i.e. press releases, poster and presentation summaries)

KEY CONTACTS:

Internal

  • Works closely with Medical and Clinical Affairs teams, cross-functionally with Marketing and R&D

External:

  • Works closely with external collaborators (i.e. investigators, physicians and researchers)

EDUCATION & EXPERIENCE REQUIREMENTS:

EDUCATION
MS or PhD in medical or scientific discipline. Background in clinical science, translational research, or oncology is preferred.

EXPERIENCE
Experience in the diagnostic/medical device/pharmaceutical field preferred. Candidates with relevant academic experience with little or no prior industry experience may also be considered.

KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)
Specific Knowledge Required:

  • Excellent written and oral communication skills, with basic understanding of scientific and technical writing
  • Can clearly and concisely communicate complex medical information for multiple audiences
  • Familiarity with ICMJE/AMA guidelines a plus
  • Experience in developing clinical, scientific, or regulatory documents
  • Ability to understand and interpret results of clinical studies, with strong understanding of statistics
  • Familiarity with oncology or diagnostics a plus
  • Experience working on cross-functional teams
  • Knowledge of project management or publication management skills and familiarity with the publication process a plus

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

  • Good multi-tasker, able to work on multiple projects, organize and prioritize
  • Accountable, meets deadlines for deliverables
  • Responsive, responds in a timely manner
  • Meticulous, detail oriented
  • Collaborative, team player, can work with many personality types

WORKING ENVIRONMENT

Establishes ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

Working conditions (inside or outside the office).

  • General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Ability to travel domestic and internationally for extended periods of time

TRAVEL

Minimal travel may be optional to congresses or meetings

PHYSICAL DEMANDS:

  • Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 25 pounds.