GxP Technical Writer
GxP Technical Writer:
Description:
Immediate need for a Technical Writer with experience in pharma/biotech to support a local client in the Boston area as they strive to meet deadlines on strategic initiatives with long-term impacts on the company.
Top 3 Technical Skills:
Experience working as a Technical Writer in clinical operations, Pharmacovigilance (PV) and Regulatory Affairs
Process Mapping using Microsoft Visio
Ideally looking for someone who has templated SOP”s in their toolbox that they can use when they come in
Job Description:
-Preferred multi-GxP experience, to include Clinical Operations, Pharmacovigilance (Safety), Reg Affairs
-Experience with process mapping – we need someone who”s familiar with Visio and helping people visualizing their processes. Process maps themselves will go into SOPs/WIs.
-Experience working for pharmaceutical/biotech companies for at least 5 years, this is looking for a senior resource
-Self-starter with strong attention to detail to meet/exceed deadlines and support strategic initiatives
Clinical Technical Writer
Clinical Technical Writer
Overview
- Supporting activities within Data Management including writing controlled and internal documentation and creating business processes, and generating training and learning content.
- Provide technical writing assistance with documents to ensure quality, compliance and consistency of writing
- Crete process maps to document work processes
- Work with SMEs to establish training requirements
Experience Requirements
- Bachelor”s degree required
- 5+ years relevant work experience in pharmaceuticals, biotech, CRO or related field
- Proficient in Microsoft Office suite of applications
- Knowledge of pharmaceutical regulations and requirements
- Experience writing controlled documents and generating learning content
- Experience leading process mapping and process improvement activities
- Understanding of Data Management principles such as study initiation, maintenance and close-out, database build, implementation, and lock.
Technical Writer
To apply for this position, please follow the link below or send your resume directly to Kim.Ladka@nttdata.comHelp. For more information please call Kim Ladka at 732-362-2602 .
Length: 1 year +
Writing Technical Specs and process documentation.
Skills Required: Learns quickly.
Minimum 2-3 writing technical specifications and User documentation. Expert in using MS Word. Ability to work with Technical staff and understand technical terms.
NTT DATA Services is a leading IT services provider and global innovation partner with 130,000 professionals based in over 50 countries. NTT DATA recently acquired Dell Services. NTT DATA Services emphasizes long-term commitment and combines global reach and local intimacy to provide premier professional services, including consulting, application services, business process, IT outsourcing, and cloud-based solutions. We are a part of NTT Group, one of the world”s largest technology services companies, generating more than $100 billion in annual revenues and partner to 80% of the Fortune 100. Visit www.nttdataservices.com to learn how our consultants, projects, managed services, and outsourcing engagements deliver value for a wide range of businesses and government agencies.
The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without r egard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.
Technical Writer
Rochester, New York
Skills : Key Words: Captivate, Visio, Lectora, EDI, RoboHelp, MS Office, Training, Technical Writer, Editor, Trainer, Illustrator, Developer, Corporate Trainer, Technical Writing, Technical Content Editor, SAP e-Learning Developer, instructor, Job in Rochester, Instructional Designer, Training Developer, Training Developer, Material developer, Editor, Online illustrator
Description : Position Details:
Client: Telecom
Job Title: Technical Writer
Duration: 12 months (Possibility of Extension)
Work Location: Rochester NY 14611
Job Description:
Top 5 skills needed:
1. Must have the ability to work independently, and be flexible.
2. Manage multiple assignments simultaneously.
3. Review, edit and proofread materials written by others as applicable.
4. Develop, write, and update technical documentation in support of our product lines.
5. Review and revise existing documentation to ensure it remains current.
Bonus Skill – Knowledge of Telecommunications
Key Words: Captivate, Visio, Lectora, EDI, RoboHelp, MS Office, Training, Technical Writer, Editor, Trainer, Illustrator, Developer, Corporate Trainer, Technical Writing, Technical Content Editor, SAP e-Learning Developer, instructor, Job in Rochester, Instructional Designer, Training Developer, Training Developer, Material developer, Editor, Online illustrator
Technical Writer III
We are looking for a Technical Writer in Monroeville, PA
Experience: More than 5 years professional experience.
Education: Bachelor”s Degree or equivalent unless otherwise specified.
Demonstrable excellence in command of the English Language required.
Strong organizational and project management skills required.
Mastery of page layout, word processing, and computer-generated illustrating using the following tools:
-In-Design
-Illustrator
-RoboHelp
-SnagIt
Job Function
Work independently on Technical Writing duties, processes and roles outlined below:
-Participates on New Product Development teams for assigned products. Prepares the labeling plan, labeling-related standard requirements mapping and executes the plan for assigned products in the US and international markets.
-Creates, revises, reviews, and approves labeling (Help Files, User Manuals, Provider Manuals, Quick Start Guides, Product Labels, Packaging Labels, etc.) for the US and international markets. Leads formal technical reviews for labeling.
-Supports internal and external quality audits related to labeling
-Supports CAPA”s as they apply to labeling
-Leads labeling process improvement efforts
-Partners with Translation Coordinator(s) throughout the execution of the associated labeling plans.
-Interfaces with Business Unit functions as needed to resolve labeling concerns
-Tracks the impact of pending domestic and global regulatory changes on labeling
-Conducts department training on labeling requirements
-Maintains proficiency in domestic and foreign regulations and standards, with a focus on labeling for assigned products and global impact.
Technical Writer
Accentuate Staffing is currently recruiting for a Technical Writer to join an established company in the RTP area. This position will be responsible for writing quality documents in support of the ISO 9001:2015 standard.
Responsibilities:
• Reports to Director of Quality and managed day-to-day by the Quality Manager
• Working meetings with the process owners from Engineering, Purchasing, Operations, Test / Validation, Quality, Customer Care, and Sales to produce the necessary ISO documentation
• Creation of Procedures, Work instructions, Templates, Forms and other required ISO documents
Requirements:
• Proficient Technical Writer in support of ISO documentation
• Proficiency across multiple MS programs including Word, Excel, Visio, etc. is preferred.
• Teamwork: the candidate must be able to communicate well with cross-functional team members and be able to efficiently collaborate with team members to achieve the project goals
• No travel required
Tech Writer
PA-Philadelphia, We have an excellent opportunity for a Tech Writer who will join the Information Development team at our client developing documentation to support software product releases. The writer will collaborate with subject matter experts (SMEs) in an agile environment to gather information and write documentation for customer delivery. The ideal candidate will be a motivated self-starter who ramps up qui
Technical Writer III
For over 30 years,
Yorktel has been the video managed services partner around the world for some
of the largest business and government agencies. With over 10,000 video systems
under management worldwide – more than any other video communications service provider
– Yorktel has the proven expertise and global reach to deliver
enterprise-quality visual communications.
Yorktel is currently
seeking an Intermediate Technical Writer who will be placed in OEST’s
Division of Technology Support (DTS). They will create all levels and
types of technical print and electronic content. They will
also perform research, analysis, collaborating with technical staff, and
coordinating writing efforts. The Technical Writer will be responsible for providing write-ups
and documentation for OEST’s technical projects such as hardware refreshes,
operating systems rollouts, computer image updates, ongoing infrastructure
changes, etc. The target receipts of the technical writer’s work would be
large audiences such as automation clients and LAN support staff and end users.
The Intermediate
Technical Writer will report directly to the Director of Strategic Programs
from Yorktel. They will also have a Team Leader assigned to
them. The position will work directly with the end customer and will
respond to customer requests regarding workload and daily
activities. The Team Lead will be the immediate interface with the
Technical Writer and may be responsible for providing a monthly status report
on activities assigned and achieved.
Responsibilities:
- The Intermediate Technical Writer will interface daily
with the end customer’s team members and receive assignments from the
customer. - The Intermediate Technical Writer will interface with
the Team Lead as well as with Program Manager. - If and when necessary, the Intermediate Technical
Writer will interface with other Yorktel team members performing related
work for the customer.
Technical
Responsibilities:
The Intermediate Technical Writer will create
all levels and types of technical print and electronic content. They
will also perform research, analysis, collaborating with technical staff, and
coordinating writing efforts.
Skills and Additional Qualifications:
- Ability to effectively present information and
respond to questions from groups of managers, clients, and employees. - Strong leadership and communication skills
- Proficient in Microsoft Office Suite
- High level of initiative and autonomy
- Excellent written/verbal communication
skills to effectively communicate at all levels with clients and Yorktel - Must be willing to apply for security
clearances, suitability and other related clearances to be able to work at
certain customer locations - Knowledge of and adherence to
York Telecom policies and procedures. - May require
occasional lifting (up to 25 lbs) - Requires extensive
sitting, standing and walking - Limited weekend
and/or night work may be required - Valid U.S.
driver’s license is a requirement and must have a positive driver’s abstract. - Must be
willing to complete background checks and drug tests as required by current or
future contracts
Join us and you will
enjoy an excellent salary and benefits package, including 401k and Flex 125
plans.
We
conform to all the laws, statutes, and regulations concerning equal employment
opportunities and affirmative action. We strongly encourage women, minorities,
individuals with disabilities and veterans to apply to all of our job openings.
We are an equal opportunity employer and all qualified applicants will receive
consideration for employment without regard to race, color, religion, gender,
national origin, disability status, Genetic information and testing, family and
medical leave, sexual orientation and gender identity or expression, protected
veteran status, or any other characteristics protected by law. We prohibit
retaliation against individuals who bring forth any complaint, orally or in
writing, to the employer or the government, or against any individuals who
assist or participate in the investigation of any complaint or otherwise oppose
discrimination.
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Technical Writer
RESPONSIBILITIES:
Kforce has a client seeking a Technical Writer in Marlborough, Massachusetts (MA).
Responsibilities:
- This person will create, revise, and / or archive documents in the document control system
- Document control and assembly of engineering documents in support of operation
- Prepare / participate in design reviews for product development
- Ensures all required signatures are included on project documentation
- Support Document Change Request (DCR) processes; word-process final version of new or revised documents for approval
- Resolve documentation issues with collaboration of subject matter experts and technical staff
- Create new and revise existing SOPs, training guides, and checklists as necessary
REQUIREMENTS:
- Bachelor”s degree in Business, Engineering or a related discipline or 5 years of document control experience; An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- 3-5 years related experience in clerical, change control process management, administrative related disciplines
- Experience with Technical Writing
- In-depth understanding of multi-level Assembly and Sub-Assembly Bills of Material (BOM”s) and configuration management
- Working knowledge of Engineering Change Orders (ECO) and / or Engineering Change Request (ECR)
- Proficient in use of product data management systems
- Documentation, specification and test protocol creation and review
- Familiarity with bio-pharma industry and regulated industry standards, guidelines and best practices
- Highly detailed-oriented with solid organization skills
- Ability to -figure things out; Understand workflow and suggest improvements
- Self-directed and motivated with ability to handle multiple tasks and synthesize disparate information
- Ability to prioritize and adapt quickly to changing needs
- Customer service oriented
- Performance driven with an understanding of how to work collaboratively with cross-functional teams
- Positive and enthusiastic attitude
- Excellent written and verbal communication skills required for documentation process
- Computer skills required
- Knowledge with Microsoft Office (Word, Excel, OneNote, Outlook), Adobe Acrobat
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Grant Writer and Manager
CORAL ACADEMY OF SCIENCE LAS VEGAS
Job Title: Grant Writer & Manager
Department: Finance
Reports to:CFO
Supervises: None
Primary Purpose/Function:
The Grant Management Specialist will be coordinating and overseeing the grant application and management process including: identification of potential new funding sources, development of funding resources for existing and proposed programs and/or services, writing grants, developing budgets, collaborating on grant applications with various members of the Executive and Site Administrators and processing, monitoring and coordinating required report evaluations on existing grants. The grant management specialist provides fiscal service and support for both central office departments as well as individual school personnel. The grant management specialist will prepare and present information regarding funding opportunities to the Executive and CASLV Board Members as updates are requested. The position will also answer inquiries from external auditors and federal, state and local agencies concerning grant information and to effectively communicate complex financial issues to employees, administrators, auditors, the general public and granting agencies.
Essential Functions
- Develops and prepares grant applications and reports.
- Develops procedures for the grant application process as needed and collaborates with appropriate personnel.
- Working under limited supervision following standardized practices and/or methods; leading, guiding, and/or coordinating others.
- Working knowledge of federal and state regulations related to area of responsibility.
- Knowledge of principles and practices of governmental accounting.
- Plans, organizes, and coordinates the centralized accounting and financial reporting for assigned grant portfolio, including: preparing annual and project budgets, forecasting revenue, estimating any carry-over of funds from one year to the next.
- Researches issues, prepares invoices/ billings and collects funds for the support of restricted fund expenditures.
- Prepares or assists in the preparation of all applicable fiscal reports for sponsored programs and ensures the timely submission thereof.
- Coordinates with key personnel at all levels of the Administrators to support proper and timely expenditure of grant funds in compliance with applicable guidelines and budget deadlines.
- Compiles year-end reports, work papers and analysis necessary for the auditors to complete the yearly audit of the grants.
- Maintains grant fiscal records and database.
- Maintains oversight of assigned grant applications on an ongoing basis to ensure compliance with fundingagencies and regulatory guidelines.
- Attends necessary technical assistance conferences/meetings at the state and federal levels.
- Performs other duties as assigned.
Knowledge, Skills and Abilities Requirement:
Responsibilities include:
- Utilization of some resources from other work units may be required to perform the job”s functions.
- Ability to prioritize and self-direct, analyze situations, identify situations where appropriate to make decisions to meet deadlines and schedules; working independently under time constraints; setting priorities while performing with minimal direct day-to-day supervision;
- Flexibility is required to work with others in a wide variety of circumstances; analyze data utilizing defined but different processes; and operate equipment using defined methods.
- Skill in researching, analyzing and evaluating complex financial data.
- Ability to communicate complex information clearly and concisely both orally and in writing.
- Ability to analyze and interpret data for accuracy. Detail oriented. Problem solving is required to analyze issues and create action plans.
- Excellent interpersonal skills, ability to provide a high level of customer service, and establish and maintain effective interdepartmental communications and relationships.
- Proficiency in various computer applications including comprehensive databases, spreadsheets and word processing software.
Education and/or Experience:
Education and Training:
An earned bachelor’s degree from an accredited college or university
1. Experience in related positions, or three years of successful supervisory experiencerelated to the administrative position.
2. Experience in technical writing to include various state, federal, and/or non-profit grant application formats.
3. Fiscal management experience involving budget creation, audit responses, and payment approvals.
Preferred Qualifications:
Bachelor’s Degree in Accounting, Finance, Business Administration or a related field.Federal grant writing experience required.
At least 2 years of general accounting experience or equivalent experience managing grants. This should include processing complex financial transactions, ensuring compliance with legal or contractual requirements, recordkeeping and preparation of monthly, quarterly and/or annual reporting.
Working Environment:
The usual and customary methods of performing the job”s functions require the following physical demands: some lifting, carrying, pushing, and/or pulling; and significant fine finger dexterity. Generally, the job requires 80% sitting, 10% walking, and 10% standing. This job is performed in a generally clean and healthy environment.
AN AFFIRMATIVE ACTION / EQUAL OPPORTUNITY EMPLOYER This employer does not knowingly discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, or national origin.
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www.caslv.org | hr@coralacademylv.org