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12408
Temp-to-Perm

Medical Writer

Location: Marlborough, MA, Massachusetts

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Medical Regulatory Writer

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration – Contract to Permanent
  • Pay rate:  $50-55/hr. or $100K 
  • Job Location:  Marlboro, MA
  • Job# bh12408

Medical Regulatory Writer

General Summary

Experienced professional which integrates medical writing knowledge throughout product labeling lifecycle with aspects of effective management and strategy. This position supports the RA function by assisting the coordination and preparation of global labeling material.

Essential Job Functions

  • Communicate global regulatory labeling requirements effectively.
  • Maintain regulatory labeling files as required by departmental and organizational procedures.
  • Assists in the planning and preparation of high-quality regulatory documents, including user manuals and device labels according to company and agency guidelines.
  • Works effectively with document management systems and related tools, templates, and procedures to ensure efficient production and publishing of documents.
  • Represents Medical Writing on cross-functional teams, including external vendors.
  • Ensures a consistent style of presentation of documents to maintain quality and ease of review.
  • Performs quality control (QC) review of labeling and may contribute to pre-publishing activities.
  • Keeps management informed on progress of documents and other project related information
  • Updates UDI/EUDAMED databases
  • Additional Regulatory functions as required.

Knowledge/Educational Requirements

  • Bachelor’s degree preferably in a scientific discipline such as Science, Pharmacy or Engineering.
  • 2 to 5 years of medical writing experience is required.
  • experience in a medical device/biotechnology environment.
  • Demonstrated problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to independently complete high-quality documents according to tight timelines.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Possesses strong written and verbal communication skills.

Essential Job Requirements

  • Ensure alignment and compliance with local and regional labeling requirements worldwide.
  • Evaluate regulatory impact of proposed design and manufacturing changes.
  • Assist in departmental SOP development and implementation pertaining to labeling.
  • Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)

 

Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

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