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25 days old

New Product Development Technical Writer & Document Manager, West Hills, CA

Kelly Services
West Hills, CA 91307
**New Product Development Technical Writer & Document Manager, West Hills, CA**



**Pay Rate:** $28/hr



**Shift:** M-F, 9-5



When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.


Increased innovation, along with substantial growth in the Transplant Diagnostics business, has resulted in a need for additional Project Management support for new product development documentation. The individual in this role will assist Project Teams achieve goals and objectives set by the Senior Leadership Team.


The New Product Development Document Manager will be expected to partner with all Departments in ensuring that the organization achieves its goals. Performance of this individuals responsibilities will require good knowledge of regulatory requirements and quality systems required for in vitro diagnostic (IVD) products.



**Responsibilities:**




+ Lead and/or participate in the development of new documents or update existing documentation used for new product development

+ Ensure consistency between documents by reviewing and editing for completeness

+ Rewrite documents to be accurate, clear and concise

+ Participate in the development and maintenance of document standards, naming/numbering conventions, and templates for Design History File (DHF) procedures, work instructions, and other relevant document types

+ Ensure that documents comply with established templates, formats and identification/naming/numbering standards

+ 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

+ Manage and control specific quality records, as required

+ The candidate should have Technical Writing experience, preferably someone with In Vitro Diagnostic (IVD) devices, who is capable of creating and finalizing highly detailed documentation in the area of IVD Verification and Validation, Instructions for Use and other design input documents

+ Excellent written and verbal communication skills, possess a strong sense of responsibility and urgency.

+ This position requires the ability to interpret data from scientific literature and clinical studies and summarize the results and in a clear, concise, and scientifically accurate manner.

+ Strong knowledge and experience in Professional Medical Writing (Medical/Clinical; Regulatory; and Safety).

+ Strong knowledge of medical device and/or pharmaceutical regulations (FDA, ISO)

+ **A minimum of 2 years of experience in document control or training, applying regulations and/or standards such: as FDA, Sirs, ISO, etc.**

+ Strong process improvement mindset; passion for quality

+ Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation)

+ Demonstrated effective interpersonal and effective teamwork skills

+ Excellent oral and written communication skills

+ Analytical & problem-solving skills/root-cause analysis

+ Strong organizational skills with high attention to detail

+ Prior experience using word processing, spreadsheet, and presentation software



Education




+ **Bachelors (Required) in a scientific or technical field**






**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-06-08 Expires: 2020-07-16

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New Product Development Technical Writer & Document Manager, West Hills, CA

Kelly Services
West Hills, CA 91307

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