Medical Writer / Senior Medical Writer

Position Overview

La Jolla Pharmaceutical Company is seeking an experienced Medical Writer / Sr. Medical Writer with industry medical writing experience to join our energetic team of professionals in San Diego, CA.  The Medical Writer responsible for clinical and nonclinical regulatory documents (e.g., study protocols, Investigator Brochures, Clinical Study Reports, Nonclinical Study Reports, Annual Reports, Regulatory Briefing Documents/Dossiers & Meeting Requests, INDs, and NDAs) as well as clinical and nonclinical publications (e.g., abstracts, posters, and manuscripts).  This position will lead writing assignments on programs in early development.   Flexibility in work hours/days is essential.

Core Responsibilities include:

  • Writes clinical protocols, clinical study reports, investigator’s brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with the project team with minimal supervision
  • Writes, reviews, and/or edits publications (manuscripts, abstracts, poster presentations, etc.)
  • Drives document writing and review processes
  • Develops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
  • Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization
  • May manage outsourced writing projects with minimal supervision
  • Assists in the development and maintenance of SOPs and writing tools, such as templates and style manuals
  • Provides training on medical writing templates, QS Procedures, SOPs, and processes within the department and across departments
  • Contributes to the development of electronic document systems and tools
  • Provides quality control (QC) review of various regulatory and medical communications documents
  • Provides project team(s) with guidance and problem resolution related to document generation
  • Takes the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
  • Undertake research in the therapy area to allow effective writing
  • Acts as an authoritative resource within specialty area to internal and external resources
  • Works effectively with colleagues from other departments in team situations
  • Ensure writing meets scientific and literary standards and meets objectives
  • Incorporate editorial comments and resolve queries to present a ‘finished’ final document

Requirements:

  • Knowledge of science or an aptitude for understanding
  • Knowledge of regulations relevant to medical writing
  • Ability to work on several projects at once while balancing multiple and overlapping timelines
  • Ability to write clearly at a level appropriate to the audience and the project with careful attention to detail and accuracy
  • Ability to assess workload and suggest prioritization to senior staff
  • Demonstrated abilities in collaboration with others and independent thought
  • Familiarity with statistical analysis

Qualifications:

  • Bachelor’s degree required; advanced life sciences degree preferred, e.g., RN, MS, RPh.  At least 3 years of medical communications writing experience with development of scientific manuscripts and pharmaceutical regulatory documents. To be considered for the Senior Medical Writer position, a minimum of 5 years of experience is required

Other skills/ abilities:

  • Working knowledge of good publication practice
  • Working knowledge of GCP, GLP, GMP, and ICH guidelines
  • Excellent written and verbal communication skills
  • Strong project management skills with ability to manage multiple projects and execute in adherence to timelines
  • Desire to work in a collaborative team setting
  • Ability to thrive under challenging deadlines and in an energetic environment
  • Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
  • Must be computer literate and proficient in Microsoft Word, Excel, Endnote, and PowerPoint
  • Comply with Company quality standards/SOPs and participate in the implementation of new SOPs

NOTE: This Job description is not intended to be all-inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.