Medical writer (Investigator Brochures) – Remote

FMD K&L - Fort Washington, PA

Temporary
Position: Medical writer

Duration: 12 months contract

Location: Remote

Responsibilities

Work with project teams to prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development.
Ensure a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards.
Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.

Basic Qualifications

Bachelors’ degree (or equivalence) and 4 years of experience as a medical writer OR Master’s degree and 2 years of experience as a medical writer
Experience preparing investigator brochure

Preferred Education/Experience

Advanced degree (e.g., Masters or Ph.D. in life sciences).
Specific knowledge of company-targeted therapeutic areas is strongly desirable.
Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
Detail-oriented with excellent inter-personal and communication skills.
Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment.
FMD K&L is an Equal Opportunity Employer / Committed to Diversity

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