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Medical Technical Writer

2 months ago

Plymouth, United States Fastnet Software International Inc Full time
Job DescriptionJob Description

Education & Experience:

  • Bachelor’s Degree required in a related field
  • Minimum of 2 years medical writing experience in the medical or pharmaceutical industry or 5 years general technical writing experience required
  • Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or a combination of these skills
  • PSUR writing experience strongly preferred
  • Literature search experience is preferred
  • Biomedical, sciences, medicine or similar health related disciplines preferred

Qualifications:

  • Excellent written and verbal communication skills
  • Experience with collaborative, cross-functional teams.
  • Excellent analytical skills and ability to manage complex tasks and manage time effectively
  • Proficient with Word, Excel, PowerPoint, Outlook, etc.
  • High level of attention to detail
  • Ability to prioritize key business objectives and respond quickly to changing priorities
  • Ability to work independently with minimal daily instruction
  • Able to multitask and work in a fast-paced environment

Travel Requirements

  • Typically requires travel less than 5% of the time

 Responsibilities:

  • Writes and contributes to Clinical Evaluation reporting deliverables including Post-Market Surveillance Plans and Periodic Safety Update Reports (PSURs), Regulatory Responses and other related documentation.
  • Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for regulatory submissions and the maintenance of clinical evaluation report files.
  • Collaborates with team members and stakeholders in planning for and supporting PSUR related projects and processes.
  • Supports additional clinical, regulatory, quality and engineering related deliverables as assigned.
  • Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Quality Engineering, and Medical Affairs in completing clinical evaluation project related deliverables.
  • Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
  • Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Reports and Plans (CER/CEP), clinician training materials, ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
  • Authors and contributes to necessary documents to regulatory submissions and communications, such as regulatory inquiries.
  • Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures.
  • Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable client SOPs.
Company DescriptionFastnet Software International Inc is a NY-based legitimate staffing organization.
We are fine to provide any required information if any job seeker wants before submitting the resume for an interesting job.Company DescriptionFastnet Software International Inc is a NY-based legitimate staffing organization. \r
We are fine to provide any required information if any job seeker wants before submitting the resume for an interesting job.

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