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Clinical Regulatory Specialist


Phoenixville, Pennsylvania
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Job Details

Minimum BA/BS in a scientific, medical (biology) discipline

At least 5-6 years medical writing experience (pharmaceutical/biotechnology/CRO) combined with scientific and regulatory knowledge, plus knowledge of the medical writing processes.

Experience in writing all phases (1-4) Clinical Study Reports (CSRs), IND (clinical protocol and Investigator Brochure), and New Drug Application (NDA) components, including Section 2.7.5 Clinical Overview, Section 2.7.3 (Summary of Clinical Efficacy), Section 2.7.4 (Summary of Clinical Safety), Integrated Summary of Efficacy, Integrated Summary of Safety

Superior communication skills (written and oral), a scientific or medical background, advanced analytical and problem-solving skills, a commitment to continuous improvement

Expert statistical data interpretation and presentation skills.

Preferred candidates will have exceptional writing and organizational skills as well as meticulous attention to detail, expertise in the analytical evaluation of scientific data, an aptitude for summarizing complex information.

Expertise in MS Word sufficient to use stylized departmental templates and to solve technical problems with MS WORD templates.

Able to effectively apply grammar and punctuation rules as they pertain to technical documents.

Complex problem-solving skills and technical expertise.

Proficiency in using Microsoft Word and general facility with other computer-related tasks

Strong cognitive abilities, including verbal reasoning, critical thinking, and analytical ability

Excellent attention to detail

Ability to use style guides (AMA, CBE, and Chicago), medical dictionaries, and guidance documents that prescribe content.Ability to interpret data from tables and graphs.

Ability to create complex Word tables.

Ability to interpret basic clinical laboratory tests (serum chemistry, hematology, and urinalysis).

Ability to research literature and to interview subject matter experts.

Ability to understand concepts of coding dictionaries (MedDRA, WHO Drug)

Ability to understand biostatistical and clinical research concepts.

Ability to understand scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.

Must have: strong understanding of medical terminology; strong computer skills including word processing, spreadsheet, database and presentation software; knowledge of FDA and ICH report guidelines and Good Clinical Practices.

Must be able to understand and interpret statistical analysis of clinical trial data; integrate basic clinical concepts and pathophysiology of disease with statistical analysis; work independently and as a team member.

Must be detail oriented, be able to meet deadlines and have a professional demeanor and appearance.

Job Type: Full-time

Required education:


Required experience:

Medical Writing: 5 years

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