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Medical Writer

Company: Aerotek
Location: Santa Ana
Posted on: January 15, 2022

Job Description:

Seeking 2 Medical Writers Location: 100% RemoteDescription: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), clients guidelines and regulatory requirements) (list is not exhaustive):oClinical Evaluation Plan (CEP)oClinical Evaluation Report (CER)oPost Market Surveillance Plan (PMS-P)oPost Market Surveillance Report (PMS-R)oPeriodic Safety Update Report (PSUR)oPost-market Clinical Follow-up Plan (PMCF-P)oPost-market Clinical Follow-up Report (PMCF-R)oSafety 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 improvementFollow publication planning and Authorship SOPs and or Work Instruction, as applicableSkills:Writing skills, medical device, Literature ReviewsTop Skills Details:Writing skills,medical device,Literature ReviewsAdditional Skills & Qualifications:At a minimum, completion of a Bachelor's in a scientific discipline (e.g. Life science, Engineering, Nursing, Medicine, etc.) is required. Additional training in regulatory, technical writing and or quality is strongly preferred. Advance scientific degree (e.g. MSc, MA, MEng, MSN, PhD, MD, etc.) is also strongly preferred. A minimum of 3 years of related job experience is required for this position. Candidates with a PhD with 1-2 years experience may be considered for this role.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, combination products (biologic/pharmaceutical and medical device), cardiovascular, oncologic, orthopedics, surgical instrumentation, pain, critical care, medication delivery, immunology, nutritional care, etc. Demonstrated knowledge and experience in quality, regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, biostatistical methods are preferred. Experience and knowledge of publication document guidances including but not limited to International Committee of Medical Journal Editors (ICJME), Good Publication Practices (GPP), CONSORT Guidelines, American Medical Association (AMA) Manual of Style, and Council of Biology Editors are preferred.Regulatory and Notified Body audit experience is preferred.Project management experience is preferred.Experience mentoring/coaching and providing training to others is preferred.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 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. Were 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.

Keywords: Aerotek, Santa Ana , Medical Writer, Advertising , Santa Ana, California

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