This Job Vacancy has Expired!

Senior Medical Writer.US HDQ

Posted on Oct 14, 2020 by Integra LifeSciences Corporation

Princeton, NJ
Health Care
Immediate Start
Annual Salary
Full-Time

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol IART.RESPONSIBILITIES

Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Essential Duties & 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.
Prepares reviews of peer-reviewed literature for inclusion in post-market surveillance reports.
Performs clinical data searches and documentation as required by various commercial and non-commercial functions
Prepares Clinical Evaluation Reports & associated documents in accordance with European Union guidance and Integra internal procedures using relevant information compiled from clinical research, peer reviewed publications, risk management files and post market data. This will also include project management of CER or PSP activities across the clinical team.
Summarizes findings and write risk versus benefit analyses and conclusions based on clinical data, peer review publications, risk management files and post market data in accordance with European Union guidance.
Prepares pre-clinical and clinical sections for regulatory documentation, such as IDE, PMA, IND, or CE-Mark Technical Dossier.
Writes clinical study protocols, 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.
Develops tools to track document status to ensure reporting requirements are met.
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.
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.
Executes on the publication plan & strategy through the development of high quality publications, abstracts, posters, and presentations.
Evaluates workloads, determines resource/outsourcing needs. Leads efforts in selection and management of contract technical writers when warranted.
Coordinates/facilitates review and quality control of clinical documents (study protocols, clinical study reports) when appropriate
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
What are we looking for?

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

OUR PRODUCTS

We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.

OUR CULTURE

We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas - big and small - are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.

OUR VALUES

We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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