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    Medical Writing Contract Project Manager

    IKCON TECHNOLOGIES Inc.
    Jersey City, NJ 07097
    Full-time
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    Job Description

    IKCON TECHNOLOGIES INC delivers exceptional IT services and solutions that provide clients with definite edge over competitors and promoting highest standards of quality. We are currently looking for a Medical Writing Contract Project Manager with one of our clients in UNKNOWN, NJ. If you are actively looking for opportunities, please send us your updated resume with your contact details. JOB TITLE Medical Writing Contract Project Manager CITY UNKNOWN STATE NJ TAX TERMS W2 EXPERIENCE 10+ Years INTERVIEW MODE Telephonic Skype JOB DESCRIPTION The Medical Writing Project Manager is a member of the Medical Solutions Medical Affairs team and is responsible for the planning, development, writing and reviewing Post Market Surveillance Plans and Clinical Evaluation Reports to support Medical Solutions devices. Primary responsibilities include managing and writing Post Market Surveillance (PMS) Plans and Clinical Evaluation Reports (CERs) according to established procedures. Additional responsibilities may be assigned. The Project Manager has medical writing experience, strong project management expertise, a thorough understanding of research methodology and the ability to develop high-quality clinical documents. Extensive knowledge of the European medical device guidelinesregulations such as MEDDEV and MDDMDR is required. The Project Manager has the ability to lead cross-functional project teams. Essential duties and responsibilities Develop and manage PMS and CER project plans, timelines, and project tracking tools. Write PMS plans using analysis done in the CER Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner. Perform periodic reviews of risk documentation, product labeling, and marketing brochures as part of the clinical evaluation process. Participate in andor perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature and state of the art to support assigned product lines. Consistently apply applicable global regulations and guidelines, as well as client policies and procedures Manage contract writers Maintain contractor agreements, CVs, and training records Maintain and update spreadsheets tracking the status for PMS Plans and CER projects Work with the manager to schedule meetings and keep track of the progress and outcomes of the projects. Work closely with Directors, managers and medical writers to schedule meetings to kick off new projects, update changes with team on the projects. Responsible for the coordination of projects by following established SOPs. Collaborate with other key stakeholders to ensure that projects are coordinated and tracked in a standardized way. Accountable for maintaining project activity tracking through meetings and associated tracking spreadsheet. Responsible for collecting, maintaining, archiving and retrieving all documents necessary to ensure compliance with SOP Technical skills Experience writing CERs andor PMS plans Experience in project management is required Ability to understand and effectively communicate scientific information respond to inquiries and address needs of key stakeholders Demonstrated ability to build positive constructive relationships with cross-functional team members Demonstrated high level of personal integrity, emotional intelligence, flexibility Understanding of the highly regulated medical device industry environment Understanding of the legal and regulatory environment Clinical background, or extensive clinical research experience in the device or pharmaceutical industry Extensive knowledge of MDD, MDR and MEDDEV regulations and guidance's Experience with Microsoft applications Core skills Strong work ethic and commitment to serve internal and external clients Proactive with a sense of urgency in managing job responsibilities Attention to detail Energy, focus, motivation and debate-friendly Analytical thinking and inquisitive mindset for investigations and problem solving Team player, "can-do" attitude and excellent interpersonal skills Ability and desire to develop good working relationships internally and externally Other Ability to work with a minimum of supervision. Ability to work in a team environment.. MINIMUM QUALIFICATIONS Bachelors or above science healthcare degree preferred and 3-5 years related medical device experience Excellent written communication skills
    Posting ID: 600053599Posted: 2021-01-19