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Medical Writer/Analyst
Eingestellt von Synectics
Gesuchte Skills: Support, Design
Projektbeschreibung
- 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.
Projektdetails
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Einsatzort:
New York, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges