Associate Director, Global Regulatory Affairs (CMC) IV

  • location: Lexington, MA
  • type: Contract
  • salary: $117.98 - $138.80 per hour
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job description

Associate Director, Global Regulatory Affairs (CMC) IV

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

location: Lexington, Massachusetts
job type: Contract
salary: $117.98 - 138.80 per hour
work hours: 9 to 5
education: Bachelors
With oversight, the position supports the preparation of clinical documents that are of high quality and prepared within timelines.

  • With oversight, supports the preparation of clinical documents.

    • The development process may include writing, interpreting and summarizing clinical and non-clinical data, and compiling information.
    • Clinical documents may include investigator brochures, clinical study reports, integrated reports, summary reports, manuscripts, abstracts, posters, and presentations.
  • May participate in ensuring compliance of clinical documents with national and international regulatory requirements and guidelines and procedures (as applicable).

    • Includes collaborating with medical editors to ensure documents are publication ready.
  • Develop knowledge of all therapeutic areas.
  • The Medical Writer I must have an academic science or clinical degree (eg BS) and exceptional writing skills, and preferably experience in scientific/medical research.
  • Excellent scientific and/or medical writing skills
  • Experience in the analytical evaluation of scientific data
  • Exceptional organizational skills and meticulous attention to detail
  • Manage multiple projects with competing priorities
  • Work in a team environment
  • Possess knowledge of computer software (especially Microsoft Word and Adobe Acrobat products; Microsoft Project and Visio are a plus).
  • May require up to 5% travel.
skills: Project Management, IND, Maa, MS-WORD, MS-Project, ICSR (Individual Case Study Report), QC Review
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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