Sr. Medical Writer

Location
Basking Ridge, New Jersey
Posted
Oct 02, 2021
Ref
REGEA0026R2401
Required Education
Bachelors Degree
Position Type
Full time

The Senior Medical Writer will be responsible for tracking his/her own writing projects, and for knowing, understanding, and ensuring adherence to regulatory guidelines and department document standards.  He/she will also be expected to ensure maintenance of document standardization through use of model documents/templates and appropriate peer review. The Senior Medical Writer will be responsible for reviewing documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR.  The Senior Medical Writer will be responsible for liaising with the appropriate matrixed team members to shape and review content of documents, and to follow up with other functional groups for materials needed for document completion. The individual in this position will work independently writing CSRs, CSPs, CSP amendments, and ICFs  in a variety of therapeutic areas.  Training on Clinical Summaries and other regulatory documents may be provided.

JOB RESPONSIBILITIES:

  • Working with the clinical team, the Senior Medical Writer will be responsible for writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Informed Consent Forms, and Patient Safety Narratives.  Opportunities to write or contribute to other Regulatory documents such as Clinical Summaries and Briefing Documents may be provided. 
  • Represent medical Writing at cross-company and TA meetings.
    • Drive document development meetings;
    • Articulate document strategy and timelines;
    • Be able to identify the correct parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss. 
    • Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly. 
  • Manage processes and organize priorities; Solve problems; Foster collaboration to resolve conflict
  • Experience writing in plain language style (for ICFs)
  • Ability to explain complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience
  • Familiarity with ICH GCP guidelines for informed consent considered a plu

Experience

  • Minimum of 7+ years of industry experience to include a minimum of 5+ years of Medical Writing experience.
  • Have written CSRs, clinical protocols, clinical protocol amendments, patient narratives, and ICFs
  • Have the ability to work independently
  • Provide appropriate input on others’ documents, including review of key contributing documents, such as the SAP
  • Proactively identify and manage projects, requiring some but not significant guidance
  • Be a team player
  • Take responsibility for his/her own professional development
  • Have the ability to comprehend key points of meetings and interactions, and follows up when necessary
  • Follow agendas for meetings; Take action and produces quality written work product
  • Be able to juggle multiple priorities and adapt quickly to new situations and new project demands
  • Escalates conflict appropriately
  • Have a good working knowledge of PDF, and Project.  Skilled in use of MS WORD.  Have used 1 or more EDM systems
  • Bachelor's degree (advanced degree preferred)