Integra LifeSciences

Compensation

Full Description

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. Essential Duties and 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. • Knowledge of European, Australian and Canadian, regulations and guidelines for medical device submissions. • Able to Identify pertinent internal and external sources of clinical data and conducts literature searches of peer review publications. • Contributes to achievement of departmental goals and operating plans • 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 Knowledge, Skills, & Abilities • 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 Qualifications: • 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. • 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 Salary Pay Range: $82,000.00 - $113,000.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/ 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. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from Integra LifeSciences on Vimeo