Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based reputed company® is a leading fully integrated biopharmaceutical solutions organization built to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only reputed company reputed company easier to work with, but to reputed company us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers reputed company their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
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Job Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities reputed company and across departments with minimal supervision. Leads the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, reputed company completing medical writing projects, on time and on budget.
• Coordinates quality and editorial reviews. Ensures reputed company documentation is managed appropriately. Leads team document reviews, and reviews documents as needed.
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Reviews statistical analysis plans and table/reputed company/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
• Mentors and leads less reputed company medical writers on reputed company projects, as necessary.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that reputed company medical writing.
• Aware of budget specifications for assigned projects, working reputed company the budgeted hours and communicating status and changes to medical writing leadership.
• Completes required administrative tasks reputed company the specified timeframes.
• Performs other work-reputed company duties as assigned.
• Minimal travel may be required (less than 25%).

At reputed company, we reputed company in providing an environment and culture in which Our People can reputed company, reputed company and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and reputed company, Company match 401k, eligibility to participate in Empl Apply tot his job Apply To this Job