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Aggregate Safety Reporting (ASR) Medical Writer

Newark Metro Area, NJ

Posted: 10/09/2019 Job Type: Scientific Job Number: JN -102019-25777


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.

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

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