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5+ years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for multiple positions in contract research related to clinical trials for drugs, biologics, and medical devices. We offer immediate job opportunities in Drug Safety, Pharmacovigilance, and Clinical Research, collaborating with university hospitals, pharmaceutical companies, and recruiting partners.


Job Description

Position: Scientific Writer – Pre-Clinical and Translational Research

As a Scientific Writer, you will collaborate with experts across scientific disciplines to prepare high-quality pre-clinical and translational manuscripts, study reports, and regulatory submission documents. Your expertise in compiling and presenting complex scientific data will be critical to the success of cross-functional teams.


Responsibilities

  • Collaborate with translational scientists and representatives from disciplines like Pharmacology, Toxicology, and DMPK (Drug Metabolism & Pharmacokinetics) to develop scientific manuscripts, study reports, and regulatory documents.
  • Review complex datasets to determine appropriate tabular and textual formats, ensuring clarity, logic, and order in presentations.
  • Review and ensure the accuracy, quality, and consistency of documents authored by peers, adhering to stylistic and format requirements.
  • Prepare pre-clinical and translational sections for regulatory submission dossiers.
  • Perform additional duties as assigned.

Skills/Knowledge Required

  • Education: Advanced degree (MS or PhD) in biological or related sciences.
  • Writing Skills: Exceptional scientific writing and verbal communication skills with a proven ability to summarize complex data.
  • Experience:
    • At least 5 years of experience authoring scientific publications, reports, or review articles, preferably in pharmaceutical fields.
    • Expertise in pre-clinical/translational writing and regulatory submission guidelines.
  • Software Proficiency: Advanced skills in Microsoft Word, Excel, data graphics tools, Adobe Acrobat, and web-based tools like LiveLink.
  • Scientific Knowledge: Strong background in pre-clinical development, translational sciences, and regulatory document requirements for the FDA and other global bodies.
  • Teamwork: Ability to collaborate effectively within cross-functional teams.

Additional Information

All your information will be kept confidential in accordance with EEO guidelines.