SOP SME Developer (Jobs in Lexington, MA)   Requirement id 70479 Job title Developer Job location in Lexington, MA Skills required Technical Writer, SOP, SME, Open Date 06-Jun-2018 Close Date Job type Contract Duration 6 Months Compensation DOE Status requirement --- Job interview type ---    Email Recruiter: coolsoft Job Description Developer: Technical Writer, SOP, SME, 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 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: 70479 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),    Technical Writer job openings in other states Jobs List BUSINESS ANALYST CONSULTANT TECHNICAL WRITER-11444-1 Create date: 14-Nov-2024 Candidate Submission Limit Per Supplier : 2 Start date : 12/10/2024 Submission deadline : 11/21/2024 Client Info : Department of Health and Human Services Note : Q) INTERVIEW PROCESS (phone, video or in-person, how many rounds of i/vs, etc.) A) In-person or video for initial intervi.... (This job is for - job Jobs in SC Columbia Consultant - (in Columbia, SC)) NCDPS - Technical Writer- Expert (745828) Create date: 28-Aug-2024 No of submissions : 2 Start date : 09/09/2024 End date : 09/08/2025 Submission Deadline : 08/30/2024 Client info : NCDPS Note : * Agency Interview Type : Either Webcam Interview or In Person * ***This is a hybrid position. The candidate will be expected to be onsite 2-3 d.... (This job is for - job Jobs in NC Raleigh Consultant - (in Raleigh, NC)) Technical Writer 4 -131652 Create date: 11-Jun-2024 * No of submissions : 2 Start date : 07/08/2024 End date : At least 3 Years from projected start date Submission deadline : 6/17 at 3 PM CST Client info : Note: * Interviews: Virtual (Teams) with camera on * 100% Remote - Candidate must live in the US UI Jobs in ND Bismark Consultant - (in Bismark, ND)) NETWORK OPERATIONS CENTER TECHNICIAN-11235-1 Create date: 31-May-2024 Start date : 6/17/24 Submission deadline : 6/7/2024 Client Info : Clemson University Note : Q) INTERVIEW PROCESS (WHO WILL CONDUCT I/V, PHONE OR IN-PERSON, HOW MANY ROUNDS OF I/VS)? A) PHONE OR ZOOM (MAY USE IN PERSON FOR FINAL) Description : -----------------------------------.... (This job is for - job Jobs in SC ANDERSON Developer - (in Anderson, SC)) VDOT Technical Writer 4 (732818) Create date: 03-Apr-2024 Hybrid start date :04/15/2024 End date :06/30/2024 submission deadline :4/8/2024 client info :VDOT Description : *Local Richmond, VA candidates please *Candidate must be willing and able to interview onsite, NO exceptinos *C.... (This job is for - job Jobs in VA Richmond Consultant - (in Richmond, VA))    Technical Writer job openings in MA Jobs List Mainframe Technical Writer -ITS43_SysAnalyst-FY13-ITD-006 Create date: 30-Aug-2012 [Note: Submission Deadline : 09/06/2012 04:00PM] [Note: End Date : 2/28/13] [Possibility of extension: Yes] Description: Augment existing mainframe staff to gather requirements and document Mainframe operating system upgrades Title: Mainframe Technical Writer • Report to the Mainframe Operatin.... (This job is for - MS Excel Jobs in MA Chelsea Analyst - (in Chelsea, MA)) ITS43-TechnicalWriter-FY12-DOT-00-RFQ-DOT Technical Writer Create date: 22-Jul-2011 [Note : Close Date: 07/26/2011 05:00PM] [Note : Resumes allowed per authorized vendor is 2.] ITS43_TechnicalWriter-FY12-DOT-001-RFQ: DOT Technical Writer / Business Analyst Job Description: Working closely with IT senior staff and IT executive management to organize project documentation and complete writ.... (This job is for - Business Analyst Jobs in MA Boston Analyst - (in Boston, MA)) (Developer: Technical Writer, SOP, SME, in Lexington, MA)

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