SOP SMEs Quality Assurance Developer (Jobs in Lexington, MA)   Requirement id 69962 Job title Developer Job location in Lexington, MA Skills required SOP, SMEs, Technical Experience, Quality Assurance Open Date 16-May-2018 Close Date Job type Contract Duration 4 Months Compensation DOE Status requirement --- Job interview type ---    Email Recruiter: coolsoft Job Description Developer: SOP, SMEs, Technical Experience, Quality Assurance Manager will reject any candidate who is not a true writer with 10+ years of only writing experience Also manager will reject anyone with pharma manufacturing writing or validation background. GENERAL POSITION SUMMARY: The Standard Operating Procedures (SOP) Technical Writer is responsible for working with Subject Matter Experts (SMEs) to prepare new or changes to existing Policies, SOPs, and Work Instructions as part of an overall document harmonization and integration project. The SOP Writer is responsible for implementing the document workflow process as a formal written procedure as well as being responsible for supporting the development and revision of procedures by applying document standards, criteria and adhering to timelines. Emphasis will be to address procedures from Global Medical Affairs, Global Drug Safety, Global Regulatory Affairs, Research, Non Clinical Development, Quality Assurance and Compliance and Global Clinical Development Operations. GENERAL RESPONSIBILITIES AND REQUIRED SKILLS X Supports the full procedural document lifecycle for Policies, SOPs, Work Instructions (WIs) and Forms by serving as a SOP Writer X Works with document owner, global process owner and SMEs to implement agreed upon procedural development applying appropriate document standards and criteria, ensuring terminology consistency across documents X Collects input from stakeholders and consolidates comments, resolving conflicts collaboratively X Translates process maps or other process representations and applies them to SOP procedures wording X Contributes to the development and maintenance of up-to-date SOP Writer procedures so that the process is used and consistently applied by all SOP Writers X Works with functional area SMEs to develop cross-functional process models X Contributes to the maintenance and updates to the SOP harmonization tracking spreadsheets and timelines, as assigned X Performs other duties, as assigned X Displays the ability to manage customer expectations X Demonstrates proactive thinking and actions X Familiar with cross-functional customer service techniques X Ability to multi-task in a fast-moving environment X Maintains tracking spreadsheets and timelines as assigned PREFERRED EDUCATION AND EXPERIENCE: X B.S in a scientific or allied health field (or equivalent degree) X 5 years of Research and Development medical writing or Research and Development SOP writing experience in the Biotech, Pharmaceutical, or Medical Device Industry, or relevant comparable background preferred X 5 years of Research and Development experience required X Experience in working in a GXP environment with emphasis on GCP, GLP, GPV, and GMP X Possesses a solid understanding of document standards, criteria and conventions X Experience working in a system for collaborative document development. X R&D Process Modeling/Process Mapping understanding and experience, a plus X Technical writing certification a plus This email and any files transmitted with it are confidential and or privileged information internal to our organization and intended solely for the use of the individual(s) or entity or entities to whom they are addressed. This message contains confidential information and is intended only for the recipients. If you have received this email in error please notify the sender by replying to this email and then delete this message and any attachments. If you are not the named addressee you may not disseminate, distribute or copy this e-mail. If you are the intended recipient you are notified that unauthorized disclosure, copy, storage, or distribution of this information is strictly prohibited.   Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 69962 while calling.   Other jobs in MA: Boston (103), Burlington (1), Cambridge (1), Canton (3), Chelsea (9), Franklin (1), Lexington (2), Malden (10), Marlborough (2), Maynard (2), Newton (1), Quincy (6), Sharon (1), Waltham (1), Welesley (1), Wellesley (6), Westborough (1), Westbourough (1), SOP job openings in Lexington, MA Jobs List Technical Writer Scientific - J-11-325-460 Create date: 06-Jun-2018 Manager will reject any candidate who is not a true writer with 10+ years of only writing experience Also manager will reject anyone with pharma manufacturing writing or validation background. They need a True Pharma R&D Writer GENERAL POSITION SUMMARY: The Standard Operating Procedures (SOP) Technical Writer i.... (This job is for - SOP SME Jobs in MA Lexington Developer - (in Lexington, MA))    SOP job openings in other states Jobs List Software Process Engineer SPS 3 A4 SC3 (725979) Create date: 11-Dec-2023 Job Title: L&I- Software Process Engineer SPS 3 A4 SC3 (725979) Start date : 01/03/2024 End date : 06/30/2024 Submission deadline : 12/13/2023 Client info : L&I Description : The incumbent in this position will serve as a Senior Quality.... (This job is for - SOP Jobs in PA DauphinCounty Engineer - (in Dauphin County, PA)) Systems Engineering Technician II - FR97670 Create date: 31-Oct-2022 start date:11/7/2022 End date:06/30/2023 submission deadline:11/04/2022 client info : OIT Note: * Position Location: Remote Description: OIT shall provide the funding necessary to support professional IT resources necessary to SOP Jobs in CO Denver Consultant - (in Denver, CO)) Product Analyst - 66440 Create date: 03-Sep-2020 Candidate must be local : Yes Job Description : Locations: (candidates can sit in any of these locations) Hoboken, NJ, Chicago, IL San Bruno, CA Walmart Media Group is looking for Ad Ops Onsite Analysts to join our team in San Bruno, Hoboken, or Chicago. We are looking for individuals who love .... (This job is for - Troubleshooting SOP QA Jobs in CA SanBruno Analyst - (in San Bruno, CA)) Administrative Assistant I Textbooks - 55408 Create date: 07-Feb-2020 Description Purpose: The client is seeking the services of an Administrative Assistant I (Textbooks) to provide support the Office of Teaching & Learning (Curriculum & Instruction). Summary: The Administrative Assistant I (Textbooks) will be based at the CLL and support school sites as requi.... (This job is for - Administrator SOP Jobs in GA Atlanta Consultant - (in Atlanta, GA)) Salesforce Architect - 58764 Create date: 31-Jan-2020 Job Description : It has an immediate opening for a Salesforce Architect to lead a proof of concept design and development effort. This is in support of one of our Enterprise level clients Health Solutions Management division, which focuses on Healthcare IT solutions for our Federal Government. This position will play a key role working .... (This job is for - Java SOP APEX Jobs in MD WindsorMill Architect - (in WINDSOR MILL, MD))     (Developer: SOP, SMEs, Technical Experience, Quality Assurance in Lexington, MA)

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