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Manager ASR Medical Writer at (BMS) Bristol-Myers Squibb in Summit, New Jersey

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Full-Time





Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

WWPS, Manager, Aggregate Safety Reporting (ASR) Medical Writer (Grade 9)

Summary:

Reporting to the Associate Director, Worldwide Patient Safety (WWPS), Aggregate Safety Reporting (ASR),  the primary role of the ASR Manager, 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:


  • Support and/or author/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 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 WWPS and other departments as needed

  • Raise any concerns regarding content or process to the Associate Director in a timely manner

Qualification/Experience Required:


  • Minimum of BA/BS/PharmD in life science or clinical science

  • Minimum of three years relevant experience in pharma/biotech, preferably with experience in 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

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.