Associate Medical Communications Manager: Medical Writing

Integra LifeSciences

8d•$82,000 - $113,000

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Associate Manager, Medical Writing is a senior level professional with advanced knowledge and experience in preparing complex clinical and medical writing deliverables.

Requirements

Advanced medical and 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.
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
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).
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
Skilled in written and oral communications.
Meticulous attention to detail.
Able to analyze, interpret, and critically evaluate complex sets of clinical and nonclinical data.
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

Nice To Haves

Knowledge of European, Australian and Canadian, regulations and guidelines for medical device submissions.
Experience with MS-Project preferred.
Medical device experience is preferred (510(k), PMA, BLA, HCTP).
Experience in regulatory writing is preferred.

Responsibilities

Prepares complex clinical deliverables in accordance with internal GSOPs, and regulatory guidelines including clinical sections for regulatory documentation as well as Literature Review Protocols, Literature Review Reports, Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance, Post-Market Clinical Follow-Up Plans and Reports within expected deadlines with little oversight.
Ability to perform and document a methodologically sound literature search with little oversight.
Able to Identify pertinent internal and external sources of clinical data and conducts literature searches of peer review publications.
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.
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.
Mentors and/or trains more junior colleagues