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Medical Writer- Remote

  • 4 months
  • Remote

Job Description

  • Must be able to accommodate PST working hours.*
  • Description:*
  • Support the preparation of regulatory documents and responses to regulatory authorities (with a focus on medical device products).
  • Contribute to the writing of the following document types (in accordance to SOP(s), client’s guidelines and regulatory requirements) (list is not exhaustive): o Clinical Evaluation Plan (CEP) o Clinical Evaluation Report (CER) o Post Market Surveillance Plan (PMS-P) o Post Market Surveillance Report (PMS-R) o Periodic Safety Update Report (PSUR) o Post-market Clinical Follow-up Plan (PMCF-P) o Post-market Clinical Follow-up Report (PMCF-R) o Safety and Clinical Performance Reports (SSCP-R)
  • Ensures the CER files and other documents are linked to the appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) for consistency and accessibility. S/he will implement (in conjunction with the Technical Writing Manager) an effective communication model for CERs with the cross functional team.
  • Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices.
  • Perform critical review and data analysis from clinical investigations and literature for incorporation into the CER.
  • Will proactively partner (in conjunction with the Technical Writing Manager) with cross functional business partners such as Medical Affairs, PMS staff, Quality, R&D, Regulatory Affairs, other vendors relating to the CER process.
  • May perform routine systematic literature reviews for specific medical devices.
  • May assist in the development of schedules to ensure CER timelines are met.
  • May participate in workshops and company initiatives to help define processes globally and provide timely CER regulatory requirements and industry best practices for continuous process improvement
  • Follow publication planning and Authorship SOPs and or Work Instruction, as applicable
  • Additional Skills & Qualifications:*
  • At a minimum, completion of a Bachelor's in a scientific discipline is required. Additional training in regulatory, technical writing and or quality is strongly preferred.
  • A minimum of 3 years of related job experience is required for this position.
  • Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation and CER document creation are required.
  • Strong computer skills in appropriate software applications and related systems required.
  • Experience in the following therapeutic areas are strongly preferred: renal, cardiovascular, oncologic, orthopedics, surgical instrumentation, pain, critical care, medication delivery, immunology, nutritional care, etc.
  • Must have strong written and oral communication skills.
  • Must have a flexible mindset with the ability to work in a fast-changing environment.
  • Experience Level:* Intermediate Level

Compensation is tied to the Colorado market for jobs performed in Colorado. Other locations may be subject to variances based on locations-related factors. We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:
  • Medical, dental & vision
  • 401(k)/Roth
  • Insurance (Basic/Supplemental Life & AD&D)
  • Short and long-term disability
  • Health & Dependent Care Spending Accounts (HSA & DCFSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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Job Detail

  • Post Date:05 Feb 2022
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