Posted to MedZilla on 9/25/2018


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

Benefits

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

Please visit our website at www.randstadpharma.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.