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Ability to meet deadlines, monitor and assess performance within deadlines and utilize resources appropriately to ensure accurate and timely deliverables. Independently gather information from technical and non-technical Subject Matter Experts to organize, develop, and write technical service content.

Job Title: Diagnostic Engineer /Customer Service Technical Content author 
Location: 
Woodridge, Illinois 
Onsite/ Remote: Day 1 Onsite at customer location 
Job Description: Diagnostic Engineer /Customer Service Technical Content author 
Experienced in vehicle mechanics for more than 4 years at service advisor or at dealership 
Experience in automotive/truck support aftermarket services 
To identify gaps between recalls and service content or repair information available for that. And provide solution accordingly. 
Prior hands on automotive/diesel experience working with step based published diagnostics 
Microsoft familiarization (Outlook, TEAMS, Excel, PowerPoint, etc.) 
Comprehends dealer facing step-based diagnostics 
Willingness to get to the root cause of the problem 
Willingness to identify problems while also proposing solutions 
Communicate effectively through phone, email, or chat 
Wanting to make a difference and challenge the process 
Being well organized and tracking identified items inside a repository 
Ability to meet deadlines, monitor and assess performance within deadlines and utilize resources appropriately to ensure accurate and timely deliverables 
Ability to multitask, prioritize tasks, and interface with many personalities 
Strong communication skills: ability to take complex engineering concepts and explain them at an appropriate audience level 
Experience with vehicle recalls and provide corrective action plans 
Independently gather information from technical and non-technical Subject Matter Experts to organize, develop, and write technical service content 
Strong Technical Diagnostic Step Based Understanding 
Strong Root Causal Understanding (LEAN, 5 Why's, 6 Sigma) 
Strong Attention to Detail (Comparing, Investigating, Identifying) 
Customer Focused (What's The Right Thing To Do) 
Good understanding of Agile environment 
Excellent verbal and written communication skills 
To work with cross-functional Teams 
Ability to Multi-task on various projects 
Strong MS Office tools experience including, Word, Excel, SharePoint and OneNote 
Extremely Organized on tasks (What Are You Working On, What Are You Waiting On, What Do You Need Help With, What Is Next In Line) 
Understanding of structured authoring (DITA) and basic knowledge of Arbortext 
Knowledge of automotive system theory, in any or all the following areas: 
Electronic and electrical fundamentals 
Mechanical procedures 
Modern automotive systems 
“*** is an Equal Employment Opportunity employer. We promote and support a diverse workforce at all levels of the company. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, age, national origin, or disability. All applicants will be evaluated solely based on their ability, competence, and performance of the essential functions of their positions with or without reasonable accommodations. Reasonable accommodations also are available in the hiring process for applicants with disabilities. 
Candidates can request a reasonable accommodation by contacting the company ADA Coordinator at 
*** 
.”

Yantran LLC

JD Diagnostic Engineer /Customer Service Technical Content author

Agile Programming Methodologies

Arbortext

Automotive Industry

Communication Skills

Corrective Action

Cross-Functional

Customer Relations

Customer Support/Service

Data Collection

Detail Oriented

Establish Priorities

Identify Issues

Lean Six Sigma

Microsoft Excel

Microsoft Office

Microsoft SharePoint

Microsoft Word

Multitasking

Organizational Skills

Performance Analysis

Presentation/Verbal Skills

Six Sigma

Technical Writing

Time Management

Writing Skills

jobdiva

With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs. For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs.Essential Functions:• With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents).
• Supervises and mentors less experienced medical writers, as necessary.
• Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.
• Strives to complete medical writing deliverables on time and within budget.
• With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines.
• Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.
• Coordinates QC reviews of documents and maintains audit trails of changes as applicable.
• Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.
• If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output).
• Performs peer review of documents written by other medical writers, as required.
• Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).
• Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
• Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
• Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.
• Brings issues and potential concerns to line manager/client oversight managers attention and proposes possible solutions for consideration by management team.
• Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.).
• Other duties as assigned.Necessary Skills and Abilities:• Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.
• Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.
• Advanced understanding of regulatory submission requirements and processes.
• Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.
• Exceptional project management skills and strong communication skills with a high attention to detail and quality.
• English language proficiency and familiarity with American Medical Association (AMA) style.
• Strong experience in relationship building and strategic collaboration on key business accounts.
• Thinks proactively, takes initiative, and willingly takes on new challenges.
• Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.
• Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed.
• Works effectively in a collaborative team environment.
• Demonstrates a growth mindset and positive outlook in all work activities.Educational Requirements:• Bachelors degree or higher, preferably in medical or scientific discipline.Experience Requirements:• Minimum of 5 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.
• Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis.We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether youre successful or not.Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

ProPharma Group Holdings LLC

Senior Medical Writer

Administrative Skills

Artificial Intelligence (AI)

Biostatistics

Biotech and Pharmaceutical

Budget Management

Budgeting

Clinical Data

Clinical Data Management

Clinical Practices/Protocols

Clinical Research

Clinical Study Publications

Consulting

Contact Management

Contract Research Organization (CRO)

Delivery Management

Diversity

Documentation Review

English Language

Entrepreneurship

FDA (Food and Drug Administration)

Healthcare Quality

ICH Regulations

Leadership

Marketing Authorization Application (MAA)

Medical Diagnosis

Medical Equipment

Medical Records

Medical Writing

Mentoring

Operations Management

Pharmacovigilance

Process Improvement

Product Lifecycle

Project/Program Management

Quality Control

Regulations

Regulatory Requirements

Regulatory Submissions

Research & Development (R&D)

Risk

Sales Management

Scientific Research

Standard Operating Procedures (SOP)

Team Lead/Manager

Team Player

OTHER

This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. Position Summary: This role provides advanced support to the Quality department in the area(s) of regulatory affairs and acts as a senior member of the Quality team to meet the goals and objectives of the department and potentially other service lines.

YEAR

Overview:
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary:
This role provides advanced support to the Quality department in the area(s) of regulatory affairs and acts as a senior member of the Quality team to meet the goals and objectives of the department and potentially other service lines. This role supports the overall quality program and serves as a liaison between the Regulatory Affairs/Quality team and other service lines of Versiti. He/she/they partners with service lines to provide regulatory affairs input on projects and everyday tasks.

Total Rewards Package:
Compensation The target salary for this position is $83,745 annually.  The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications. Benefits Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

Responsibilities:
<ul><li>Core Quality Responsibilities * Supports Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards. * Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. * Supports internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors. * Reviews charts, tables, etc. to analyze quality metrics. Identifies areas requiring action based on quality metrics. Communicates and works collaboratively with service lines to develop appropriate actions. * May review and approve standard operating procedures, validation plans and results, corrective action plans associated with events, and other required documents for regulatory affairs, as required. * Reviews regulatory and standards changes/updates for impact on existing processes. Communicates changes/updates to service line management. * Participates and may lead in the development, compilation, and submission of regulatory submissions as required. * May review, analyze, approve, and monitor events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions. * Completes the review of events to assess impact. * Acts a resource for regulatory and quality matters.</li><li>Specific Senior Regulatory Affairs (RA) Specialist Responsibilities * Authors and prepares documentation for regulatory submissions * Provides internal and external regulatory guidance and development of regulatory strategies * Maintains awareness of changes in global regulatory requirements for effective regulatory submissions and production documentation * Maintains facility registrations for Versiti * Review documentation and make determination of submission to regulatory agencies, as applicable * Coordinates and consults with other functions on the content and assembly of regulatory documentation and ensures consistency, completeness, and adherence to standards for all the regulatory submission * Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed * Leads and tracks regulatory projects * Support junior-level RA Specialists in project execution and/or day-to-day RA tasks</li><li>Performs other duties as assigned</li><li>Complies with all policies and standards</li></ul>

Qualifications:
Education<ul><li>Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) required</li><li>Master's Degree preferred</li></ul>Experience<ul><li>4-6 years of experience in related field required</li><li>4-6 years of experience with a master's degree required</li><li>Experience in Regulatory Submissions and facility registrations required</li><li>Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred</li></ul>Knowledge, Skills and Abilities<ul><li>Advanced knowledge of the principles and practices within Regulatory Affairs (requiring academic preparation and experience)</li><li>An experienced professional qualified in Regulatory Affairs, and possess experience in other complex technical area(s)</li><li>Requires advanced knowledge and application of external standards and regulations that impact related disciplines.</li><li>Determines and implements a course of action based on regulations, standards, and guidelines, and may modify processes and methods as required</li><li>Requires knowledge of company policies, practices, and procedures or ability to quickly gain applicable knowledge</li><li>Require knowledge and application of external standards and regulations.</li><li>Ability to use professional concepts and company's policies and procedures to solve a variety of problems</li><li>Strong written communication and business acumen skills</li><li>Proficiency in Microsoft Office</li><li>Possess strong attention to detail</li><li>Ability to read, interpret and disseminate applicable regulations and standards</li><li>Advanced knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred</li></ul>Licenses and Certifications<ul><li>Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE, RAPS RAC) preferred</li></ul>Tools and Technology<ul><li>Personal Computer (desktop, laptop, tablet) required</li><li>General office equipment (computer, printer, fax, copy machine) required</li><li>Microsoft Suite (Word, Excel, PowerPoint) required</li><li>Gap Assessment Tools for Standards/Regulations required</li></ul> <ul class="job-list-job-card__tags"><li class="job-list-job-card__tag t-14 t-black--light">#LI-Hybrid</li><li class="job-list-job-card__tag t-14 t-black--light">#LI-AB1</li></ul>

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JD Diagnostic Engineer /Customer Service Technical Content author Yantran LLC

Senior Medical Writer ProPharma Group Holdings LLC

Senior Regulatory Affairs Professional Versiti, Inc.

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