Job Details

  • Title: Medical Writer
  • Code: RCI-8601
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 10/09/2019
  • Duration: 6 Months
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  Job Description




Aggregate Safety Reporting (ASR) Medical Writer



Reporting to the Associate Director, Global Drug Safety & Risk Management (GDSRM), Aggregate Safety Reporting (ASR), the primary role of the ASR Medical Writer is to provide formatted Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Addendum Reports and US Periodic Safety Reports (PSRs) in publishing-ready format.


Responsibilities include, but are not limited to, the following:

  • Author and create ASRs (PSURs, DSURs, Addendum reports and US PSRs) as assigned, using the appropriate template
  • Provide PSURs in Periodic Benefit Risk Evaluation Report (PBRER) format
  • Provide documents according to approved templates
  • Follow the project schedule for each report
  • Update and edit ASRs during review cycles
  • Ensure thorough review of documents (both self-review and peer review) for data accuracy, consistency, correct use of grammar and consistency with the client style Guide prior to sharing with ASR team for review
  • Ensure consistency of DSURs and PSURs for the same compound for the same reporting period
  • Review of previous DSURs, PSURs, and PSUR assessment reports to ensure consistency of content
  • Attend training as appropriate/assigned
  • Attend report Kick off, Strategy and Comment Resolution meetings
  • Support other Medical Writers’ activities as needed
  • Liaise with ASR team members as needed
  • Liaise with other members of GDSRM and other departments as needed
  • Raise any concerns regarding content or process to the Sr Director in a timely manner


Qualification/Experience Required:

  • Minimum of PharmD, MS, or the equivalent combination of relevant education and professional experience (BS with appropriate experience will be considered)
  • Minimum of five years relevant experience in pharma/biotech writing, preferably in PV writing
  • Experience with safety databases (ARISg or similar) and their output
  • Expertise in Medical and/or Scientific Writing


Knowledge/Skills/Competencies Required:

  • English language expert; strong writing, editing and proofreading skills
  • Excellent communication skills (written & oral)
  • Familiarity with AMA style guide
  • Ability to integrate, analyze, interpret and summarize data from a variety of sources in a clear and concise manner.
  • Demonstrated high degree of independence with effective presentation, proofreading, and interpersonal skills to ensure a team-oriented approach
  • Understanding of medical terminology and statistical methods
  • Strong proficiency in MS Word, Excel, Outlook, PowerPoint
  • Experience with the use of SharePoint
  • Experience with the use of document management systems
  • Ability to demonstrate a familiarity with principles of PV and to interpret and present clinical and post marketing data
  • Ability to work as part of a team, multi-task and meet internal and regulatory deadlines
  • Strong knowledge of clinical trials & drug development
  • Strong knowledge of FDA and EMA regulations and guidelines, as well as ICH guidelines
  • Appreciation of the global safety environment, international regulations & guidance documents
  • Understanding of safety data capture in CT & PM settings
  • Familiarity with safety database output, preferably ARISg and Business Objects
  • Knowledge of interpretation & presentation of aggregate safety data
  • Knowledge of commercial drug environment
  • Clinical knowledge of therapeutic area patient populations & drug classes
  • Meticulous attention to detail
  • Critical thinker
  • Organization and planning skills
  • Ability to interpret, analyze and clearly present scientific & technical data (oral & written)
  • Ability to work on a global multifunctional team
  • Strong competence in information analysis
  • Able to work with minimal supervision
  • Ability to thrive in a global matrix environment
  • Confidence in making decisions
  • Sense of urgency