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Medical Writer
Ref No.: 19-14329
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Medical Writer in Summit, NJ with one of our top client.
Job Title: Medical Writer                     
Job Id: 19-14329
Location: Summit, NJ 07901
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
Summary
  • 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) has 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 
Contact
Savitha Divakaran
Direct: (732) 272 0299 | Email: Savitha.D@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com