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Senior Medical

Company: Integra LifeSciences Holdings Corporation
Location: Princeton
Posted on: June 13, 2021

Job Description:

Overview

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours.

Responsibilities

The senior medical writer is primarily responsible for preparing, with minimal supervision, Clinical Evaluation Reports (CERs), Publication Plans, and clinical literature reviews for a variety of purposes, including Post Market Surveillance, FDA Annual Reports, and relevant marketing purposes. . The senior medical writer will prepare clinical study reports, investigator brochures, manuscripts for publication, posters, abstracts or internal white papers. The senior medical writer will develop tools, procedures, and processes as required to enhance the capabilities of the medical communications function.

ESSENTIAL DUTIES AND RESPONSIBILITIES

* Creates content, writes new content, makes changes/edits to existing content. * Identifies pertinent internal and external sources of clinical data and conduct literature searches of peer review publications. * Performs clinical literature searches and documentation as required by various commercial and non-commercial functions * Prepares Clinical Evaluation Reports & associated documents in accordance with EU MDR and Integra internal procedures This will also include project management of CER activities related to Post Market Surveillance and Post Market Clinical Follow-Up.. * Prepares clinical sections for regulatory documentation, such as IDE, PMA, IND, or CE-Mark Technical Dossier. * Authors clinical study reports, manuscripts for publication, posters, abstracts or internal white papers. * Partners with subject matter experts, including liaising with external services, to develop technical content that meets regulatory requirements, and to achieve specific and immediate business objectives. * Forecasts, manages, and meets project deadlines and budgets. Takes the initiative to report on project status; anticipates and alerts manager and internal customers of potential project difficulties. * Develops tools, templates, best practices and standard operating procedures to ensure efficient preparation of high-quality medical writing deliverables. Ensures template sections of documents remain current and consistent across documents/Business Units as applicable. * Develops and maintains effective working relationships with co-workers, internal customers, and external vendors. * Manages external vendors/contractors, including review of technical and clinical writing, and invoices/payments as required. * Develops/executes on publication plans & strategy through the development of high quality publications, abstracts, posters, and presentations. * Mentors and/or trains more junior colleagues

Knowledge, Skills, & Abilities

* Advanced technical writing skills & presentation skills * Demonstrated bibliographic research and editorial skills. * Strong ability to interpret and disseminate relevant product information. * Proficiency in MS Office applications and proficiency in or ability to learn EndNote or Reference Manager. * Basic understanding of regulatory compliance for medical devices. * Strong organizational skills, attention to detail and proofreading skills. * Maintains general knowledge of industry, regulatory, marketing, linguistic, and publication standards and applies this knowledge to the completion of all projects. * Demonstrated project management skills. * Ability to produce reports and documents independently and evaluate the writing of others. * Demonstrated creativity and ingenuity through the development of novel, multi-disciplinary approaches to projects and strategic issues. * Skill and ability in implementing strategic projects, acting as a catalyst to remove organizational barriers, reduce cycle times and direct process improvements. * Ability to rapidly develop expertise in the company's internal document management system

Qualifications

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

* Minimum BA/BS plus 8 years experience in pharmaceutical/biotechnology industry (5 years for PhD/PharmD level), with at least 5 years as medical writer (3 years for PhD/PharmD). * Expertise with software and templates commonly used in regulatory medical writing (ie, MS-Word, Excel, Powerpoint, Adobe Acrobat). Experience with MS-Project preferred. * Works well and efficiently in fast-paced environment across multiple functional teams. Has solid understanding of the different clinical and regulatory development functional areas and roles. * Positive, flexible, open-minded attitude; thrives in collaborative environment * Medical device experience is preferred (510(k), PMA, BLA, HCTP). * Experience in regulatory writing is preferred. * Skilled in written and oral communications. Meticulous attention to detail. * Able to analyze, interpret, and critically evaluate complex sets of clinical and nonclinical data. Prepares documents that present clinical data objectively in a clear, concise format. * Experience in design control processes is preferred. * Experience in protocol development, data analysis and report writing in clinical or non-clinical studies. * Experience in study design and data analysis. * Comfortable leading teams and educating team members as needed during process of document development * Organized, results-oriented, deadline-driven. Experience managing multiple projects * Comfortable taking the initiative, solving problems at hand, and escalating issues as needed

Keywords: Integra LifeSciences Holdings Corporation, Trenton , Senior Medical, Other , Princeton, New Jersey

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