Medical Technical Writer

4 weeks ago

Ridgefield, United States CYNET SYSTEMS Full time
Job Description:

Pay Range $53.05hr - $57.05hr
  • Manages and writes/edits relevant sections of global clinical documents, required for advancing clinical development programs in global, cross-functional study and project teams.
  • Manages all technical aspects of GMW document development as well as publishing and archiving activities and is the interface to Global Regulatory Operations.
  • Accountable for Patient Narrative process and final delivery including coordinating the strategy, overseeing the process, managing timelines with cross-functional teams, and interfacing and overseeing the vendor to ensure timely and successful document finalisation.
  • Responsible for the preparation of relevant content for global clinical documents (CTPs, IBs, CTRs, ICFs, or other relevant clinical documents) including the planning and set up in the document management system for authoring teams, the planning and strategy for document development, and the overseeing of timelines.
  • Requires proactive and continuous cross-functional coordination with functional areas outside of GMW as well as external vendors or CROs to ensure timely and successful document finalisation.
  • Manages and is accountable for all technical steps for document development.
  • This may include the set-up, organization, and standard content management for various document types as well as overseeing and managing the publishing and archiving activities for global clinical documents managed by GMW.
  • The Medical Technical Writer serves as the interface between GMW and Global Regulatory Operations.
  • Ensures quality of the deliverables that are outsourced to vendors/CROs that are writing clinical trial reports or other clinical regulatory documents and acts as the interface to systems that are not accessible to external vendors.
  • Develop in-depth knowledge in the technical writing area and stays on top of new developments and industry standards. Understand and utilize document formatting and writing conventions and standards.
  • Exchange knowledge with Global Medical Writers and ensure new ideas are integrated and implemented within GMW.
Skills:
  • The job involves working in global, cross-functional study and project teams, coordinating, and supervising a time-sensitive technical process with cross-functional involvement.
  • Additional complexity is introduced by external providers and awareness of cultural diversity.
  • The job requires handling numerous complex tasks simultaneously.
  • Sound knowledge of document management systems, clinical documents standards, clinical trials, their documentation, and regulatory requirements.
  • Deep knowledge of international writing standards and conventions and regulatory writing.
  • Sound knowledge of safety reporting and regulatory requirements.
  • Ability to proactively identify problems and initiate improvements.
  • Understanding of the business impact of timelines for clinical documents.
  • Excellent written and verbal sound knowledge of MS Office (especially Word, Adobe), Microsoft 365, document management systems, and high IT affinity.
  • Places a high priority on regulatory compliance and quality.
  • Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers.
  • Ability to manage parallel tasks and variable workload.
  • Strong interpersonal and social skills, ability to communicate effectively in international cross-functional teams, cultural sensitivity.
Education:
  • Master s degree with a minimum of 2-3 years or a bachelor s degree with a minimum of 3-5 years of working experience, preferably in e.g. natural sciences, pharmacy, medicine or digital technologies, project management or communication science or any other relevant field with at least 3 years of professional experience preferably in clinical operations or related areas; alternatively vocational training
  • Associate s degree, technical college e.g. in medical documentation or other relevant fields, with at least 5-8 years of professional experience and preferably 3 years of experience in technical writing, clinical operations or related areas.

  • Technical Writer

    4 days ago

    Ridgefield Park, United States EPITEC Full time

    EpitecPOSITION:Technical WriterJOB TYPE:W2, Full-time, ContractLOCATION:Ridgefield Park, NJJOB SUMMARY FOR TECHNICAL WRITER:The Content Engineer is needed to create service related contents for STG upload. The Content Engineer will be creating contents with focus on upcoming new models and high service trend models. Content Engineer is crucial to resolve the...

  • Medical Technical Writer, Fully Home Based

    1 month ago

    Ridgefield, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionOutside EST ZONE candidate requested not to apply.Duties:Manages and writes/edits relevant sections of global clinical documents, required for advancing clinical development programs in global, cross-functional study and project teams. Manages all technical aspects of GMW document development as well as publishing and archiving...

  • Technical Writer

    1 week ago

    Ridgefield Park, United States Yoh, A Day & Zimmermann Company Full time

    Jr. Technical WriterLocation: Ridgefield Park, NJSchedule: Fully onsite• Tech Guide or similar experience (i.e. manuals, parts info, service bulletins, etc.)• Someone who enjoys hands-on physical product parts and analysis type work; “Hobby technician” per-say – someone who enjoys building and taking apart technical products• When the...

  • Technical Writer

    1 week ago

    Ridgefield Park, United States Yoh, A Day & Zimmermann Company Full time

    Jr. Technical WriterLocation: Ridgefield Park, NJSchedule: Fully onsite• Tech Guide or similar experience (i.e. manuals, parts info, service bulletins, etc.)• Someone who enjoys hands-on physical product parts and analysis type work; “Hobby technician” per-say – someone who enjoys building and taking apart technical products• When the...

  • Technical Writer

    1 week ago

    Ridgefield Park, United States Yoh, A Day & Zimmermann Company Full time

    Jr. Technical WriterLocation: Ridgefield Park, NJSchedule: Fully onsite• Tech Guide or similar experience (i.e. manuals, parts info, service bulletins, etc.)• Someone who enjoys hands-on physical product parts and analysis type work; “Hobby technician” per-say – someone who enjoys building and taking apart technical products• When the...

  • ServiceNow Trainer and Writer

    5 days ago

    Ridgefield Park, United States Samsung SDS America Full time

    Company Overview: Samsung SDS is the digital arm of the Samsung group and a global provider of cloud and digital transformation innovations. Samsung SDS delivers enterprise-grade solutions and services in cloud, secure mobility, analytics / AI, digital marketing and digital workspace. We enable our customers in government, financial services, healthcare, and...

  • ServiceNow Trainer and Writer

    4 days ago

    Ridgefield Park, United States Samsung SDS America Full time

    Job DescriptionJob DescriptionCompany Overview:Samsung SDS is the digital arm of the Samsung group and a global provider of cloud and digital transformation innovations. Samsung SDS delivers enterprise-grade solutions and services in cloud, secure mobility, analytics / AI, digital marketing and digital workspace. We enable our customers in government,...

  • Technical Sourcing Recruiter

    2 days ago

    Ridgefield Park, United States Samsung SDS Full time

    Samsung SDSA is looking for a technical sourcing recruiter to support our recruiting process from start to finish. Working alongside the rest of the IT Talent Acquisition team, you will play an integral role in growing our company. You will apply your project management, analytical and data-centric skills to increase hiring efficiency, own all system...

  • Technical Sourcing Recruiter

    2 days ago

    Ridgefield Park, United States Samsung SDS America Full time

    Samsung SDSA is looking for a technical sourcing recruiter to support our recruiting process from start to finish. Working alongside the rest of the IT Talent Acquisition team, you will play an integral role in growing our company. You will apply your project management, analytical and data-centric skills to increase hiring efficiency, own all system...

  • Technical Sourcing Recruiter

    4 days ago

    Ridgefield Park, United States Samsung SDS America Full time

    Job DescriptionJob DescriptionSamsung SDSA is looking for a technical sourcing recruiter to support our recruiting process from start to finish. Working alongside the rest of the IT Talent Acquisition team, you will play an integral role in growing our company.You will apply your project management, analytical and data-centric skills to increase hiring...

  • Director of Grants Development and Pre and Post Award Administration

    5 days ago

    Ridgefield, United States Community Health Center, Inc Full time

    Job Description Summary:Job Description:The Director, Grants leads the Pre and Post Grant Award team of the Moses Weitzman Health System Government and Public Sector Grants department. The MWHS was built on the principle that healthcare is a right, not a privilege and includes the Community Health Center, Inc. (CHCI), Weitzman Institute, National Institute...

  • Director/Senior Associate Director, Medical Affairs Strategy Team Member

    4 days ago

    Ridgefield, United States Boehringer Ingelheim Full time

    Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize...

  • IT Project Team Rockstar

    3 days ago

    Ridgefield, United States CorCystems, Inc. Full time

    Job DescriptionJob DescriptionAre you a strong technical professional who wants career advancement opportunities in a flexible, fun and exciting team environment? Then CorCystems is the place for you! We are a Managed IT Services company located in Ridgefield, CT. and are searching for a Project Team Rockstar to join our winning team. As a Project Team...

  • Licensed Practical Nurse

    4 days ago

    Ridgefield, United States Maplewood at Danbury LLC Full time

    Licensed Practical Nurse, LPN  Shift Available: 3p-11p Maplewood at Danbury 22 Hospital Ave, Danbury, CT 06810 Want to know what makes our employees eager about going to work every day? The people we serve. Being a part of Maplewood requires passion and a desire to help others. Each employee has the ability to touch the hearts of all our seniors and be a...

  • Licensed Practical Nurse

    4 days ago

    Ridgefield, Connecticut, United States Maplewood at Danbury LLC Full time

    Licensed Practical Nurse, LPN Shift Available: 3p-11pMaplewood at Danbury 22 Hospital Ave, Danbury, CT 06810Want to know what makes our employees eager about going to work every day? The people we serve. Being a part of Maplewood requires passion and a desire to help others. Each employee has the ability to touch the hearts of all our seniors and be a part...

  • Licensed Practical Nurse

    2 days ago

    Ridgefield, United States Maplewood at Strawberry Hill Full time

    Licensed Practical Nurse, LPN Shift Available: Full Time 3p-11p Maplewood at Strawberry Hill. 73 Strawberry Hill Ave East, Norwalk, CT 06855 Want to know what makes our employees eager about going to work every day? The people we serve. Being apart of Maplewood requires passion and a desire to help others. Each employee has the ability to touch the hearts...

  • Solution Architect

    5 days ago

    Ridgefield, United States EverView Full time

    Job DescriptionJob DescriptionOSG are seeking a talented Solution Architect (Remote) to join our team to help support and facilitate our growth and expansion of services. OSG is changing the way customers interact with businesses they care about. Designing and taking to market customer first solutions that change the way consumers see information through a...

  • Veterinary Technician

    5 days ago

    Ridgefield, United States United Veterinary Care Full time

    Description Position at Quarry Ridge Animal Hospital Veterinary Technician located in Ridefield, CT , is growing and we are seeking a Veterinary Technician to join our awesome team . QRAH is a large multi-doctor progressive and overall fun place to work where there is an environment of camaraderie, compassion, respect, and commitment to providing...

  • Product Specialist

    1 week ago

    Ridgefield Park, United States Aditi Consulting Full time

    Summary: The main function of a product specialist is to be the subject matter expert on a product through its development. The typical product specialist will provide technical advice to customers concerning their product Skills required: Maintain a high level of technical knowledge within the Compny’s Dacor Home Appliance and Electronic Products,...

  • Product Specialist

    4 days ago

    Ridgefield Park, United States Aditi Consulting Full time

    Summary: The main function of a product specialist is to be the subject matter expert on a product through its development. The typical product specialist will provide technical advice to customers concerning their product Skills required: Maintain a high level of technical knowledge within the Compny’s Dacor Home Appliance and Electronic Products,...