Medical Writer
Medical Writer needed in Suburban Philadelphia, PA
The medical writer will be an integrated member of the Clinical & Medical Affairs and Regulatory Affairs teams, working closely with both to manage all aspects of document preparation for clinical documents and regulatory submissions according to company guidelines and international governmental regulations.
- The medical writer will be in a blended role as an integrated member of the Clinical & Medical Affairs and Regulatory Affairs teams, working closely with both to manage all aspects of document preparation for clinical documents and regulatory submissions according to company guidelines and international governmental regulations.
- The Medical Writer will have a lead role in planning and preparation of clinical and regulatory documents (e.g., study protocols, Investigator Brochures, clinical study reports, IND applications, Health Authority meeting material, and clinical and administrative sections of clinical trial and marketing authorization applications, periodic reports).
Requirements necessary to apply:
- Advanced degree (MS or Ph.D.) in a relevant scientific field preferred
- 5+ years of industry experience as Medical Writer
- Experience in ENT/allergy/respiratory therapeutic areas is a plus
- Experience in preparing clinical documents related to late phase studies
- Experience writing protocols and CSR’s
- Experience in preparing summary level documents (e.g., Investigator’s Brochures, Annual Reports, Safety Updates)
- Strong knowledge of other key submission documents (e.g., Summary of Clinical Safety, Summary of Clinical Efficacy, Clinical Overview and regulatory submissions)
- Experience working with standard document templates/styles to support electronic (eCTD) submissions
- Experience reading SAS tables and output from statisticians, and ability to translate rough data into embedded tables in documents
- Candidate must have strong MS word formatting skills
For immediate consideration please forward resume to TMaksym@Jouleinc.comHelp
Technical Writer
Come join us and grow your career with CTG! CTG has worked with this international, Fortune 500 end-client for over 10 years! Apply with CTG for this exciting opportunity!
Job Title: Technical Writer
Project Duration: Contract Position, 10 months with possible extension beyond 2018
Project Location: Big Flats, NY (near Elmira)
Work Hours: Monday – Friday; 8am – 5pm
PPE: Standard will be provided (Rx Safety glasses will not be reimbursable)
Day to Day Responsibilities:
| Support the Design, Acceptance, Installation, and Validation of Large Scale Manufacturing Process Equipment, per GAMP (good automated manufacturing practices).
At the beginning of the capital project, gathers and compiles equipment design requirements to generate the user requirements specification (URS). Monitors the project life cycle, updates the URS, if needed, generates the functional requirements specifications (FRS), and based on the final design, generates the machine acceptance documents (FAT/SAT). During equipment installation, creates, writes, and edits operational, instructional, and maintenance documents required for the operation and support of the process and process equipment. Conducts interviews with users and technical staff to gather data for documentation. Researches and translates technical information into manuals for nontechnical users. Verifies document content on actual machine, confirming actions and responses are correct. Manages library of support documents and interfaces with the Quality department to ensure compliance to CPT and GAMP requirements. Produces products that conform to the company documentation and quality assurance standards. Utilizes existing templates and recommends format improvements to meet technical and customer requirements. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has internal and external contacts.
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Preferred Skills:
- Education: AAS preferred
5+ years of dedicated Technical Writing in a “High” technology setting - Experience with GAMP and/or documentation of new equipment builds and installation in a manufacturing environment
- Should be comfortable working in a team environment where it is necessary to proactively solicit input and feedback from users and stakeholders
- Should be familiar with process automation equipment, including HMI”s, PC interfaces, and instrumentation used to operate a large manufacturing process machine
Additional Information
- No third party resumes will be accepted
- Drug testing and/or other employment-related inquiries may be conducted
- All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third party vendors)
- Candidates must currently reside in USA or Canada
- CTG is an Equal Employment Opportunity employer
- CTG is an E-Verify Company
CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
CTG”s greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Service Writer
Service Writer
Take your career to the Summit…
At Summit Truck Group, one of the country’s leading heavy duty truck dealer groups, our success depends on serving our customers with the best team members in the industry. If your career goals include making a valuable contribution as a Service Writer in an exciting and growing company and working with top professionals in the industry then consider joining our team.
Summit Truck Group in Lubbock, TX is seeking an enthusiastic, hard-working, customer-oriented individuals who can work in a team environment as a Service Writer.
The Service Writer will interview customers and write down symptoms with their truck, enter data into the business system correct, coordinate incoming repairs with the service supervisor, invoice customer tickets, keep customers informed about current status repairs.
Responsibilities:
- Interview customers about issues with their vehicle, get information from the vehicle and enter into the business system.
- Communicate with the service supervisor about incoming jobs.
- Coordinate job status and quotes with customers.
- Invoice customer pay tickets and prepare warranty repairs.
- Open the building and parking lot in the morning and close both in the evenings.
- Maintains safe and secure environment by following safety and security standards and procedures; complying with codes.
- As other duties assigned by manager.
Qualifications:
- Superior customer service skills.
- Highly detailed oriented.
- Ability to function in a fast paced customer focused environment.
- Strong written/verbal communications skills.
- Knowledge of truck specifications.
- Warranty Clerk experience highly preferred.
- 1-3 years of experience in the trucking/transportation industry.
- Commercial valid driver’s license and clear driving record.
About our Company: Summit Holdings is a privately held company that does business as Summit Truck Group, Summit Bus, and Summit Lease & Rental. The company operates 31 commercial truck and bus dealerships in Arkansas, Kansas, Mississippi, Missouri, New Mexico, Oklahoma, Tennessee and Texas. Summit Truck Group represents and services International®, Kenworth, Volvo, Mack, Ford and Isuzu commercial trucks, and Crane Carrier specialty vehicles. Summit Truck Group delivers exceptional customer service through its more than 1,300 employees, 440 technicians, and 458 service bays.
Summit Truck Group is an Equal Opportunity Employer and a drug-free workplace
Medical Content – Oncology Medical Writer
LAWRENCE TOWNSHIP, NJ
Project Description:
Monitor medical literature, guidelines and data releases at congresses for company and relevant competitor data to develop oncology content for slide decks, Q&As, Medical Information standard responses, training resources, and other deliverables while maintaining scientific accuracy and complying with applicable laws, regulations, guidance and Client policies and procedures.
- Develop and update medical communication content per clinical development program, publications, data releases, congress activity, customer inquiry trends, treatment landscape, market events, etc.
- Conduct literature searches, author medical communications content and perform data accuracy reviews for medical communications content on Client oncology assets.
- Literature search: identify and review all relevant data available in published literature to ensure in-depth and relevant medical data is reflected in all deliverables.
- Medical writing: author medical standard responses, Q&As, slide decks, and training materials that are succinct and scientifically rigorous.
- Data accuracy review: perform data accuracy reviews of all deliverables to ensure all content is supported by available data/references.
- Support development of training deliverables on disease state, product overviews, and relevant market events to ensure readiness to address customer inquiries.
- Consistently maintain in-depth knowledge of oncology and evolving competitive landscape.
Required Skills:
- PharmD, PhD, or MD with a minimum of 1 year experience in a Medical Affairs function within the Pharmaceutical Industry.
- Oncology and medical writing experience is strongly preferred.
- Strong scientific/medical writing skills evidenced by good quality writing of Medical Affairs communications and/or publications in peer-reviewed journals.
- Ability to navigate clinical protocols, clinical study reports, investigator brochures, publications and medical congress materials.
- Understanding of the benefits and limitations of different data sources (i.e., abstracts vs publications, primary vs tertiary data).
- Able to work independently after receiving appropriate guidance.
- Excellent organizational skills with ability to prioritize, multi-task and work in a fast-pace environment.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Michelle: michellea@alphaconsulting.comHelp
ALPHA”S REQUIREMENT #18-00299
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Technical Writer
Contract position: TECHNICAL WRITER contract opportunity at a highly regarded manufacturing firm near Tampa, FL. Projected 12+ month assignment. Local candidates.
Responsibilities for the Technical Writer• Develop TPM (Total Productive maintenance) to produce Preventive maintenance work instructions for both maintenance and operators on equipment involving hydraulics, pneumatics, electrical, and mechanical items
• Spend 30% of the time out on the manufacturing floor and working in manufacturing environments
• Interface with maintenance, operators and with OEM”s to retrieve any missing information.
Requirements for the Technical Writer
• Minimum AS degree in a technical area
• Minimum 3+ years experience in Technical writing
• Strong mechanically inclined apptitudes
• A PLUS to have experience creating preventive maintenance documents
• Strong interpersonal/verbal skills interfacing with production floor maintenance and production team as well as strong technical writing skills
Benefits
• Pay rate in range shown
• Contractor Benefits
• Exposure at a top manufacturing firm
• Projected 12 month assignment
• Local candidates
Technical Writer III
PRIMARY FUNCTION
The position of a Technical Writer III provides direct support of the Logistics department by creating technical content for technical publications, including instruction manuals, procedural information, and all other supporting documentation to effectively communicate complex technical information.
ESSENTIAL FUNCTIONS
- Develop technical content for various technical publications including installation, maintenance, and troubleshooting procedures.
- Research and write plans, reports and input briefing documents.
- Serve on proposal teams in support of project development and responses to Statement of Work (SOW).
- Participate in validations and verification of technical publications, as required.
- Coordinate publication efforts with functional departments, to include Integrated Logistics Support (ILS), Logistics Analysis, Technical Illustrations and Publications Development.
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Coordinate with the Engineering point of contact to interpret drawings and translate requirements into usable technical instructions / procedures.
- Explain technical ideas in simple language in easy to interpret instructions.
- Prepare any visual aids such as charts, graphs, forms, etc. to accompany technical documentation.
- Provide updates and newly revised editions of technical documentation for end users.
- Other duties as assigned.
SUPERVISORY RESPONSIBILITIES
This position has no supervisory responsibilities. This position has the responsibility and authority to carry out assigned tasks.
Job Requirements:
KNOWLEDGE, SKILLS, & ABILITIES:
- Working knowledge of MIL-PRF-63002, MIL-PRF-63029, and MIL-STD-40051 standards.
- Advanced computer skills specifically using Microsoft Office Suite; advanced knowledge of Microsoft Word; ability to learn additional computer skills or software programs.
- Strong analytical skills. Must be able to interpret large of amounts of data and isolate pertinent information and facts
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write complex and technical reports and correspondence
- Excellent interpersonal skills to work effectively and cooperatively with all levels of management and staff.
- Must be trustworthy.
- Effective oral and technical written communication skills to effectively and clearly communicate complex information in high pressure, emergency situations to others.
- Ability to use general office equipment such as fax, phone, copier, etc.
- Ability to follow processes and procedures.
- Strong professional customer service skills, including active listening, prompt service and follow-up.
- Excellent analytical skills with the ability to evaluate data and consider decision impact across multiple areas with limited information in high stress situations and environments
- Strong decision analysis and problem solving skills; ability to draw conclusions and justify decisions. Must be able to communicate issues to management and regulatory agencies.
- Ability to learn and understand corporate policies and procedures and how they relate to company’s goals.
- Ability to multi-task efficiently.
QUALIFICATIONS:
- BA/BS Degree or commensurate experience and 5 years of task related experience
- Working knowledge of MIL-PRF-63002, MIL-PRF-63029, and MIL-STD-40051
- Must be well versed in the use of Microsoft Word, Excel, Outlook, SharePoint and PowerPoint
- Ability to maintain a government security clearance
Yulista offers an excellent compensation and benefits package. We are an Equal Opportunity / Affirmative Action Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disabilities, protected military or veteran status. To apply for this position, or view all of our job openings, visit us online at www.yulista.com, click on career opportunities.
Click Here To Apply
https://yulista.hua.hrsmart.com/pm_module/cgi-bin/click.cgi?job_id=1686&site_id=35
Proposal Writer
Position Title: Proposal Writer
Position Schedule: 8-hour day
Location: Vienna, VA
Minimum Clearance: Ability to obtain and maintain a government security clearance
Brief Overview of Position:
Strategic Operational Solutions (STOPSO) is actively seeking a Proposal Writer to support our rapidly expanding business. We are looking to add this position to our team to support a robust pipeline of large, complex opportunities. Our growing company provides for an energetic work environment where high performance is rewarded with new exciting opportunities for professional growth. We work hard to create an environment where individuals are recognized and rewarded for their contribution to our success. You will be responsible for managing the entire business proposals cycle. You will work with several Directors and Technical Managers while managing the proposal process including writing and editing (contributor and editor) in support of the overall proposal effort.
Description of Duties:
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Participate and support in all aspects of proposal development including kick-off, management, content development, editing, and desktop publishing
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Support proposal strategy and planning discussions during the capture phase of an opportunity
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Manage proposal support resources to meet deadlines and deliver a quality product
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Leverage industry best practices and contribute to the development and continuous improvement of proposal engineering processes, tools, and templates
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Analyze various RFPs/SOW to determine structure and requirements of the response in accordance to the appropriate contract vehicle
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Develop proposal schedules, outlines, templates, and assist in the maintenance and management of proposal content
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Write and synthesize proposal/marketing narrative in near-real time as required. Leverage existing archived proposal information
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Develop targeted questions and interview technical and programmatic staff to extract the critical information necessary to develop technical and managerial solutions
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Lead and participate in color reviews. Performs quality checks and reports progress against schedule and compliance on a continuing basis to appraise management of status
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Proofread and edit proposal text, project summaries, and resumes for proper grammar, spelling, comprehension and style
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Work with the Managers to develop and articulate technical and management solutions
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Communicate proposal-related requirements and status with senior management, as appropriate
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Define and manage the proposal response schedule
Qualifications and Education:
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5-7 years of relevant experience; 3+ years of combined experience as a proposal coordinator and proposal manager including a successful track record of supporting complex Federal Government bids, including GWACs and IDIQs
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1-3 years of experience overseeing junior writers
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An “ownership” mentality and willingness to actively participate in developing winning proposals
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Experience in supporting the development of proposal content to fill gaps in resource availability through strong verbal and written communication skills
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Proven ability to help develop and effectively incorporate key messages, win themes and solutions
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Must be very proficient with MS Office, including Excel, PowerPoint, Word, MS Office and experience working with queries in databases
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Preferred experience working with small to mid-size government contracting
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Experience with IT and Intelligence Community Analysis and various DoD agency experience
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Excellent writing skills and high proficiency in organizational structure
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U.S. citizenship and eligibility for Security Clearance
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Bachelor’s degree from an accredited institution
Strategic Operational Solutions, Inc. is an IT strategy and management company specializing in delivering solutions to enhance business operations in the Federal sector across DoD, DHS, the Intelligence Community, and the Law Enforcement Community. We partner with each client to provide customer-centric solutions that achieve current mission requirements and realize strategic vision. Successful outcomes require integration and coordination across a spectrum of disciplines.
Leveraging the talent and experience of our employees, STOPSO provides its services in the following concentration areas:
• Identity Management and Biometrics
• Engineering and Information Technology Requirements and Development
• Information Assurance and Cybersecurity
• Security Studies and Analysis
Please visit us at www.stopso.com
*MON*
Content Writer
We’re looking for talented writers to create 1-3 articles per week.
Requirement for each article:
1,000 – 2,000 words on topics related to video, audio or website accessibility
Use simple words that are easy to understand
Use a conversa
Cerner Report Writer
Notes:
- Qualified candidates must be able to pass a Criminal background check before starting work.
- Must work 40 hours a week, Monday – Friday
- Best to live in or close proximity to Orange County
- In person interviews only
PROJECT OVERVIEW:
The scope of this effort is to organize and conduct “in class instructor lead training” for all CLIENTstaff to effectively use Microsoft Windows 10.
The project is the implementation of a client-wide Windows 10 training. This is a (1) one year assignment meant to train approximately 2800 agency staff in the use of Windows 10 as their PC’s are migrated from previous versions of Windows 7 and 8 to Windows 10.
Starting in mid-2017 Client IT embarked in an initiative to migrate all Laptops and Desktops to Windows 10 in an effort to remain in best practice and for staff to have the latest Microsoft operating system. It is expected to have all staff using Windows 10 by end of 2018.
Required Skills:
A. Solid background in teaching IT related skills
B. Strong experience in supporting hardware and software
C. Strong experience with MS Office and Windows 7, 8 and 10
D. Familiar with Citrix, Citrix print environment and MS Active
Directory
E. Able to troubleshoot various issues and basic peripherals using remote tools.
F. Able to convey technical information clearly and concisely over the phone to end users
MUST BE ABLE TO PERFORM THE BELOW: (Dual Role)
CLIENT is in search of contract person to lead a classroom of approximately 15 staff (per session) through visuals and hands on demonstrations of Windows 10 operating system utilizing Client’s curriculum. This training will span from beginning to intermediate usage of Windows 10.
When not engaged in training the selected individual will be working at the CLIENT Service Desk taking inbound calls and help in the resolution of 1st and 2nd level service requests.
MUST BE ABLE TO PERFORM BELOW TASKS:
* Assist participants with hands on instruction
* Maintain calendar for training
* Take classroom attendance and note “no show” and missed classes
* Make recommendations to introduce items into the existing curriculum