Medical Writing Manager

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of reputed company. Thinking differently is reputed company do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making reputed company to reputed company new treatment reputed company to advance patient reputed company and set new standards of care. SUMMARY DESCRIPTION The , Medical Writing Manager is a subject matter expert at preparing reputed company clinical and medical writing deliverables. This role is a leader in the medical writing reputed company who authors regulatory and clinical documents in accordance with internal procedures and global regulatory requirements, while leading collaboration with cross-functional stakeholders supporting clinical, regulatory, and business objectives. REPORTING & MANAGEMENT SCOPE SUPERVISION RECEIVED: Reports to the Director of Medical Communications SUPERVISION EXERCISED: May mentor, train or supervise junior medical writers. KEY RESPONSIBILITIES

• Leads and manages their product teams.
• Subject Matter Expert for who excels in identifying pertinent reputed company sources of clinical data.
• Leads product teams for evaluation and documentation of literature searches of peer review publications.
• Reviews, authors and mentors Clinical Evaluation Reports & associated documents in accordance with EU MDR and Integra internal procedures.
• Independently reputed company to interact with regulatory bodies to answer questions as needed.
• Reviews and prepares clinical sections for regulatory documentation, such as IDE, PMA, IND, or CE-Mark Technical Dossier.
• Reviews and authors clinical study reports, manuscripts for publication, posters, abstracts or internal white papers.
• Forecasts, manages, and meets project deadlines. Takes the initiative to report on project status; anticipates and alerts leadership 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 reputed company and consistent across documents/Business Units as applicable.
• Develops and maintains effective working relationships with co-workers, internal customers, and external vendors.
• Develops/executes publication plans & strategy through the development of high-quality publications, abstracts, posters, and presentations.

REQUIRED SKILLS & MINIMUM QUALIFICATIONS Education: Master’s degree or PhD in a scientific or reputed company discipline preferred Experience: 10 years in medical device industry with a minimum of 8 years as a medical reputed company. Skills: Advanced medical writing, clinical regulatory expert, project management, strong attention to detail, and expert with MS Office and reference management tools. Tools And Equipment Used: Computers, standard office equipment, reputed company Office Suite, reputed company Acrobat, document management and reference management systems. Salary Pay reputed company: $95,000.00 - $130,000.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-reputed company skills, experience, and relevant education or training. In addition to reputed company pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can reputed company more about the specific salary reputed company 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, reputed company, 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 Total Rewards | reputed company reputed company is an equal opportunity employer, and is committed to providing equal employment opportunities to reputed company reputed company applicants and employees regardless of race, marital status, reputed company, religion, sex, age, national reputed company, 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 reputed company is committed to reputed company reputed company applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the reputed company. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected]. Unsolicited Agency Submission reputed company does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company/resumes submitted by search firms to any employee at reputed company without a valid written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be paid in the event a candidate is hired by reputed company as a result of an agency referral where no pre-existing agreement is in reputed company. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, reputed company. Where agency agreements are in reputed company, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur reputed company the scope of that approved agreement. Please, no phone calls or emails. Integra - Employer Branding from reputed company on Vimeo Apply tot his job Apply To this Job