Career Opportunity: Medical Writer

Position Summary

Manages the timely development and completion of clinical reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration, World Health Organization and/or other regulatory organizations.  May oversee the electronic regulatory submission process.  Oversees and provides recommendations for the development of formats and guidelines for documentation.  Provides guidance and direction for completion and development of clinical and pre-clinical documents.  Ensures effective planning and management of timelines for all aspects of technical documents. May prepare scientific manuscripts, abstracts and posters.  May also support clinical research associates and medical doctors in clinical protocol development.  Keeps abreast of professional information and technology through conferences.

The position reports to the Chief Medical Officer.

 

Responsibilities

  • Write/edit regulatory documents or parts thereof (e.g. CSRs, DSURs, RMPs)
  • Participate in planning of analysis and data presentation to be used in study reports or summary documents.
  • Act as a member of clinical trial teams following protocol finalization
  • Act as documentation consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.
  • Act as project medical writer for various programs in clinical development and ensure medical writing resource allocation to studies within these programs.
  • Supervise outsourcing to external medical writers, if necessary in conjunction with mentoring medical writer. Follow and track clinical trial milestones and resource requirements for assigned projects.
  • Proficiency at authoring/editing CSRs, experience authoring/editing multiple other types of clinical regulatory documents (eg, study level, program level, health authority responses), including authoring clinical/scientific abstracts, posters, and manuscripts.
  • Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables.
  • Ability to effectively communicate in oral presentations.
  • Ability to identify problems and develop approaches to solving them.
  • Manages ambiguity and works through conflict to create consensus.

 

Requirements

  • A bachelor’s degree in Life Sciences/Health-Related Sciences or equivalent experience.
  • 6+ years experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment.
  • Extensive experience writing clinical study reports, eCTD documents or similar, or protocols for Early Phase, Phase II or Phase III trials.
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
  • The ability to manage multiple and varied tasks with enthusiasm and to prioritize your work while paying attention to details.
  • Fluency in written and spoken English.
  • Position is located in the Zynerba office, Devon, PA.

 

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