Medical Writer/Analyst

New York  ‐ Onsite
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Keywords

Description

Creates documents pertaining to clinical data and post-marketing safety data, such as briefing documents for regulatory agency meetings, periodic safety reports on products, Risk Management Plans, and responses to safety questions from regulatory authorities. The primary focus of the role will be to support/lead the preparation of the Risk Management Plan.
  • Provide guidance on regulatory requirements and corporate policies related to regulatory submissions documents
  • Provide guidance on analysing and presenting data and on benefit-risk assessment
  • Evaluate document requirements and complexity, and identify information gaps.
  • Proposes or contributes to strategies to resolve any identified issues.
  • Analyze clinical data, post-marketing safety data, review the medical literature, and similar related activities.
  • Produce documents that meet SOPs and regulations. Alert teams and management to any issues
  • Provide clear, factual, effective, and concise analyses and discussions
  • Assure the accuracy and quality of information presented in assigned documents.
SKILLS:

4-7 years experience in Oncology required
  • Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
  • Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
  • Strong oral presentation skills, including ability to present, explain and defend data analyses before internal and external (including Regulatory Authority) audiences
  • High fluency in written English and strong functional fluency in spoken English. Knowledge of additional languages is an asset.
  • Familiarity with global regulatory guidance relevant to clinical and safety data.
  • Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel) is preferred.
  • Proficiency with statistical concepts and ability to carry out statistical analyses is desirable.
  • Extensive familiarity with epidemiologic principles and concepts is desirable.
  • Must have at least a BS degree in life sciences. MS, PhD, PharmD, MD preferred. Alternatively, Bachelor's or higher degree in field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas.
  • A minimum of 5 years of experience in pharmaceutical industry is required.
  • Able to conduct and interpret analyses of safety and design routine analyses that support pharmacovigilance activities
  • Knows and interprets safety-related guidance's in context of specific products and safety issues.
  • Is able to synthesize analyses of aggregate or individual patient data into clearly written text with no supervision.
Start date
n.a
From
Synectics
Published at
04.02.2014
Project ID:
660531
Contract type
Freelance
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