Technical Writer, Toxicology Job

TECHNICAL WRITER, TOXICOLOGY needed for a CONTRACT opportunity with Yoh's client located in Summit, NJ.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Scientific writing
- Pharmacokinetics
- FDA submissions

WHAT YOU'LL BE DOING:

- Technical writing of reports for non-GLP nonclinical pharmacology and/or exploratory toxicology studies conducted within Translational Development or Experimental Toxicology/Therapeutics and/or by external collaborators.
- Writing and/or reviewing nonclinical pharmacology, pharmacokinetics, and toxicology summaries for IND, NDA, and CTD applications to Health Authorities.
- Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
- Working with other relevant line functions to prepare/review regulatory documents and submissions, including Investigator Brochures, Phase I clinical protocols, integrated summaries of efficacy and safety, registration dossiers, company core data sheets, product monographs/package inserts, and responses to health authorities.
- Follow internal guidelines for document preparation.
- Follow templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
- Participate in study and project team meetings and assist the teams in resolving issues related to document preparation.
- Work with NCD Document Specialist and Regulatory Operations department to initiate and maintain electronic study report and published literature repository, and contribute to the authoring, review, and approval process for documents within an electronic publishing system.
- Attend Product Development Team meetings and Department Group Meetings to become informed in upcoming needs for nonclinical writing.
- Implement the strategy for document preparation and NCD review that includes timelines that meet or exceed company standards and the document review processes.
- Review work of other writers (in-house or contract) for accuracy, quality, focus and adherence to format and stylistic requirements.
- Other duties/responsibilities as assigned.

WHAT YOU NEED TO BRING TO THE TABLE:

- Advanced degree in biological/toxicological or related sciences, MS or PhD with three to five (3-5) years of professional scientific writing experience.
- Will consider a BS degree with several years of related experience.
- Must have experience as a nonclinical toxicology, pharmacokinetics, and/or pharmacology writer that included contributions to Investigational New Drug (IND), New Drug Application (NDA), and/or Common Technical Documents (CTD) and electronic document submissions (eCTD) for Food and Drug Administration (FDA) submissions, and nonclinical & regulatory documents included in registration dossiers for worldwide use.
- Familiarity with toxicology, in vivo animal studies, pharmacokinetics, pharmacology, cell biology, and biochemistry required.
- Proficiency in use of Microsoft Word, Excel, Adobe Acrobat, and web-based browser software such as LiveLink to manage electronic document authoring, reviewing, and approval process.
- Knowledgeable in nonclinical development including toxicology, pharmacokinetics, and discovery pharmacology.
- Knowledge of FDA and ICH guidelines.
- Ability to work with multiple complex projects and within cross-functional teams
- Excellent technical scientific writing and verbal communication skills required.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

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