Principal Medical Writer - CA or Remote

Company: Artech LLC
Location: Irvine
Posted on: November 25, 2022

Job Description:

Job Title : Prin Medical Writer
Location : Irvine, CA
Duration : 12 Months

Description :
Top 4 skills below.
--- Prior experience in scientific/regulatory writing (for clinical evaluations, clinical investigations, and/or regulatory submissions)- for Senior Medical Writer
--- Strong project management skills - ability to manage multiple high-priority projects at once
--- Team player with strong oral/written communication skills
--- Keen attention to detail

Candidate pay rate should not exceed ***/hr for Prin Medical Writer.

Candidate can work remotely anywhere in the US.

Description

Position Description:
The Medical Writer/Senior Medical Writer will support our Neurovascular Medical Affairs organization. This Writer will develop clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards.

Position Responsibilities:
--- Lead the development and completion of Clinical Evaluation Plans/Reports (CEPs/CERs) as part of design validation for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CEPs/CERs
--- Work in a cross-functional team and draft clinical investigation plans (CIPs), clinical study reports (CSRs), investigator brochures (IBs), and Annual Progress Reports
--- Provide support with submissions to regulatory agencies by drafting clinical sections of global submissions (eg, IDE, PMA)
--- Collaborate with the Quality organization and perform Clinical Risk-Benefit Analysis (CRBAs) to support risk management activities
--- Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies
--- Collaborate with Regulatory Affairs and provide support to respond to questions from regulatory agencies
--- For all documents, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers
--- Conduct literature searches and clinical evidence mapping, manage the literature database and prepare literature reviews for external and internal stakeholders
--- Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders
--- Contribute to post-market surveillance activities by keeping abreast of newly published scientific literature on assigned devices and report to complaint handling unit, as required
--- May attend major national & international conferences to keep up to date with advancements in the field; contribute to the development of conference coverage reports for internal distribution
--- Develop and maintain SOPs and writing tools, such as templates and style manuals

Required education/experience:

Requires a University Degree and minimum 7 years of relevant experience, or advanced degree in a scientific discipline (Ph.D., MD, or Pharm. D.) with a minimum of 5 years of relevant experience.

Other pre-requisites:
--- Experience in the development of clinical, scientific, and regulatory documents including CERs preferred
--- Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
--- Excellent project management and organizational skills
--- Ability to understand and interpret results of published literature and clinical studies; working knowledge of statistics is required
--- Ability to summarize complex results and present in a clear, concise, and scientifically accurate manner to a wide-range of audiences
--- Excellent writing and editing skills, and a keen attention to detail
--- Strong verbal, written, and interpersonal communication skills
--- Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote
--- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment
--- Expertise in conducting focused literature searches on PubMed, MedLine, or other similar medical literature databases

Duration: 1-year contract with potential to convert to a full-time position

Location: Irvine, CA or remote anywhere in the US

Keywords: Artech LLC, Irvine , Principal Medical Writer - CA or Remote, Education / Teaching , Irvine, California