Posted to MedZilla on 3/24/2019

Randstad Pharma

Medical Writing 20128-MZ


Job Title: Medical Writer

Position Description

  • Writes and oversees the preparation of clinical study protocols, clinical study reports, Investigator's Brochures, clinical pharmacology sections of US and EU clinical trial applications and marketing applications, and other high-level summary, briefing, and response documents in accordance with international guidelines.

    - Performs macroediting of documents for organization, content, structure, and tone, and to ensure documents are consistent, and microediting of documents for punctuation, grammar, sentences, paragraphs, and writing styles.

    - Coordinates the review, revision, quality control, quality assurance, electronic publishing, and approval of documents.

    - Develops/Maintains standards and processes.

    - Follows Company Safety, Health, and Environmental policies and procedures.

    - Performs other projects and duties as required/assigned.

  • Scientific Background: Clinical pharmacology with experience in Abuse liability document writing preferred.

    Functional Knowledge: World-wide government regulations pertaining to drug development and regulatory documents in support of clinical research.

    Industry Related Knowledge: Worked independently within an interdisciplinary, global team. Project management experience.

    Technical Knowledge: Proficient in the Microsoft Office suite of applications/functionality, and use of electronic document management systems

    Language: Excellent English, both written and spoken.

    Competencies Ability to manage multiple priorities and work well under time constraints. Writing/document preparation/document organization, communication, collaboration, organizational, cross-function team skills. Data interpretation and summarization. Attention to detail. Ability to plan, write, review, and edit a variety of clinical and scientific regulatory documents and ensure that these documents adhere to applicable regulatory guidelines, and departmental and editorial standards.

Position Requirements

  • Experience : 4-8 years in CNS Therapeutics and Phase 1 regulatory medical writing. Experience in writing Phase 1 clinical protocols and CSRs, IBs, PSP and PIPs, and submission documents is highly desirable.

    With consideration given to education, previous relevant work experience, and transferable skills

  • Graduate in the life sciences or related discipline (biology, pharmacy, medicine); Masters/PharmD/PhD level


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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