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Documentation Specialist
4 weeks ago
Cypress HCM Irvine, United StatesDocumentation Specialist · The Documentation Specialist who will be responsible for supporting the manufacturing of products by creating, processing and reviewing production batch records. The Doc Specialist will follow established GDP & GMP processes and procedures. · Summary: · ...
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Label Production Artist
1 week ago
Arrowmac Irvine, United StatesAbbVie is searching for a talented Label Production Artist to join our pharma client's dynamic team In this role, you'll play a vital role in ensuring our artwork is accurate, impactful, and meets the highest standards. · What You'll Do: · Channel your creativity to develop and e ...
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Sales Operations Coordinator
3 weeks ago
Induce Biologics USA Inc. Irvine, United StatesThe Sales Operations Coordinator strengthens the commercialization strategy by assisting field management in the onboarding of new customers and distributor partners, as well as facilitating customer fee schedules and reporting/analytics. Key to the role is managing field request ...
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Senior Graphic Designer
1 week ago
US Tech Solutions Irvine, United StatesClient: Pharma Client · Job type: Contract · Duration: 3 - 6 Months Contract · Location: Irvine, CA (Hybrid) · Title: Artwork Developer / Graphic Designer II · Job Description: · The Artwork Developer creates and edits product packaging artworks to support new product introduc ...
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Customer Service Representative
3 weeks ago
Induce Biologics USA Inc. Irvine, United StatesInduce Biologics is commercializing a family of bioimplants that includes Natural Matrix Protein (NMPTM) which replicates the body's native healing capabilities in order to create natural bone regeneration. The NMPTM proprietary process unlocks the growth factors naturally found ...
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Ultimate Staffing Irvine, United StatesHiring for a great medical device company in Aliso Viejo, CA. Please apply with your resume if you are interested. · Title: Professional Education Assistant · Pay range: $20 to $30 per hour - Final compensation will depend on experience. · Full time schedule · Mon-Thur in offic ...
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Production Artist
1 week ago
Onward Search Irvine, United StatesOnward Search is a specialized staffing and talent solutions company that helps professionals find top jobs with the nation's leading brands. We're looking to hire a Artwork Developer ( Production Artist - Packaging) to join one of our clients in the Pharma industry · **Duration ...
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Corporate Medical Video Producer
2 weeks ago
Authentica Media Irvine, United States Full timeREAD THESE INSTRUCTIONS FIRST. ** 1) DO NOT USE EASY APPLY- we can't turn it off but we will not review Easy Apply applications. 2) Please only apply to the gmail if you have corporate AND medical / science experience + field producing with heavy interviewing, and mention these h ...
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Director, R&D Engineering
4 days ago
Edwards Lifesciences Irvine, United StatesInnovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving pat ...
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Project Manager
1 week ago
Ekman Associates Irvine, United StatesTitle: Project Manager / Sr. BSA Location: Hybrid / Onsite in Orange County, CA Ekman Associates, Inc. is a management consulting firm that specializes in developing business, digital, and technology strategy, delivering solutions, and addressing human resource demands. Summary: ...
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Senior Medical Writer
3 weeks ago
Medtronic, plc Irvine, United StatesLead the development and completion of Clinical Evaluation Plans/ Reports (CE - Ps/ CE - Rs) as part of design validation for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and r Medical, Writer, Neuro, Senio ...
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Senior Business Systems Analyst
6 days ago
Ekman Associates, Inc Irvine, United StatesTitle: Senior Business Systems Analyst / Project Manager · Location: Hybrid / Onsite in Orange County, CA · Ekman Associates, Inc. is a management consulting firm that specializes in developing business, digital, and technology strategy, delivering solutions, and addressing human ...
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Engineer
58 minutes ago
Katalyst Healthcares and Life Sciences Irvine, United StatesResponsibilities: Direct experience in Design development of combination products, or Medical Devices. Working knowledge of system engineering, risk management, usability, all the phases of design controls (end to end), global regulatory submissions, high volume manufacturing of ...
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Clinical Trial Manager
3 weeks ago
Provident Research Inc Irvine, United StatesWe're Hiring Clinical Trial Managers · Major Medical Device Sponsor (division of Major Pharma. Co.) · We're seeking Clinical Trial Managers with 4 to 7 years of study management experience presently working for a Sponsor or CRO. CPM's with Drug and/or Medical Device experience ...
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Sr Supply Planning Analyst
3 weeks ago
Insight Global Irvine, United StatesInsight Global is seeking an experienced supply chain planning professional to work for a large life sciences company local to Irvine, CA. This role will be a 6 month contract covering for a full-time employee. There will be no possibility of full-time hire, but this role allows ...
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Senior Regulatory Affairs Specialist
3 weeks ago
Infosoft, Inc. Irvine, United StatesJob Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearan ...
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Clinical Safety Coder III
2 weeks ago
Collabera Irvine, United StatesHome · Search Jobs · Job Description · Clinical Safety Coder III (Remote) · Contract: Irvine , California, US · Salary: $42.00 Per Hour · Job Code: 348851 · End Date: · Days Left: 26 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to C ...
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Digital Marketing Specialist, THV
1 week ago
Edwards Lifesciences Irvine, United StatesInnovation starts from the heart. Heart valve disease and critical care therapies impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more ...
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Director, Global Regulatory Affairs
3 weeks ago
AbbVie Irvine, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
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HRIS Analyst
11 hours ago
Ekman Associates Irvine, United StatesTitle: HRIS Analyst Location: 100% Onsite in Orange County, CA Ekman Associates, Inc. is a management consulting firm that specializes in developing business, digital, and technology strategy, delivering solutions, and addressing human resource demands. Summary: Seeking a HRIS An ...
Junior Technical Writer-Med. Device/Pharma - Irvine, United States - Kelly Science, Engineering, Technology & Telecom
Description
Kelly FSP Science and Clinical is currently seeking a Technical Writer 1 for a long-term engagement with one of our Global Pharmaceutical clients. This position is onsite 2-3 days per week in Irvine, CA. Please let me know if this is a position of interest to you and we can schedule a call to discuss this opportunity
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
General Purpose
Reports to the TW 4 or higher. Support Engineers with preparing, technical documents and manuals, explain complex information in a clear and concise manner and working with scientific staff to ensure accuracy of product descriptions. Responsible for documenting and managing change requests and ECO's to ensure complete traceability in a compliance environment.
Duties And Responsibilities
Writes and/or edits technical materials such as reports of research findings, regulations in technical areas, technical manuals, specifications or scripts on technical subjects. Provides written and oral reports, abstracts, summaries, charts, graphs, or other products.
Develops information and analysis to select and present information on the specialized subject in a format and at a level suitable for the intended audience.
Analyzes and review the preparation and organization of complex research.
Prepares written documents, including reports, articles, formal proposals, memoranda, and formal correspondence.
Edits reports and assists in or directs the development and presentation of the information.
Analyzes changes to various projects and prepares reports of changes for review.
Organizes and coordinates assignments that involve complex, novel or obscure problems and/or special requirements for analyzing and organizing information.
Lead and/or participate in the development of new documents or update existing documentation used for new product development
Participate in the development and maintenance of document standards, naming/numbering conventions, and templates for procedures, work instructions, and other relevant document types
Support/manage document workflow and ensure compliance
Ensure that document reviews and approvals are managed in an efficient and effective manner
Assist in the identification and removal of old/obsolete procedures and work instructions, as required
Collaborate within department and cross-functionally to meet set objectives and execute against manufacturing schedule.
Performs other related duties as assigned
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
Education/Training/Experience
Bachelor's degree
Minimum 2 years in a similar position.
Technical writing knowledge in the medical device industry, preferably
Prior experience using word processing, spreadsheet, and presentation software
Excellent written and verbal communication skills, possess a strong sense of responsibility and urgency
Strong process improvement mindset; passion for quality
Demonstrated effective interpersonal and effective teamwork skills
Analytical & problem-solving skills/root-cause analysis
Strong organizational skills with high attention to detail
Practical knowledge of project management, preferably
