Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision. Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical). Lead cross-functional...

• Effectively collect and evaluate data, information, and input from multiple sources to create a cohesive content strategy for writing projects. • Develop abstracts, posters, slide-decks, and manuscripts (complex) from various data sources including clinical study reports, protocols, etc. • Create slide decks for product information, diseases information. • Develop materials that are scientifically accurate, medically relevant, and adhere to the required branding guidelines within the stipulated time. • Understand and define client requirements at the project kick-off stage; develop and fact-check scientific content across therapeutic areas. • Compliant to various pharma regulations and publication guidelines and ensuring that it is supported by authentic and up-to-date references. • Ensure data are presented in a clear, complete, accurate, and concise manner.

Role Description We are searching for the best talent for a Senior Medical Writer, Scientific Operations, to join our MedTech Team. Remote work options may be considered on a case-by-case basis and if approved by the Company. The Senior Medical Writer, Scientific Operations provides oversight and execution of: - Clinical Evaluation Reports (CER) - Summary of Safety and Clinical Performance Reports (SSCP) - State of the Art Reviews (SOA) - Systematic Literature Reviews (LRR) They also support broader initiatives and general Scientific Operations activities to support the continuous process improvement activities of the Scientific Operations Team. Key Responsibilities - Planning and writing CERs, SSCPs, SOAs, and LRRs as well as mentoring other writers. - Conducting technical reviews to ensure document accuracy and compliance with local procedures, J&J guidelines, and regulatory requirements. - Managing daily activities to ensure timelines are met. - Participating in workshops and other initiatives to help define and continuously improve process efficiency. - Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices. - Supporting interactions with respective Notified Bodies and regulatory agencies. - Supporting audits and inspections pertaining to SciOps processes and deliverables. - Actively partnering with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs. - Responsible for communicating business-related issues or opportunities to the next management level. - Responsible for following all Company guidelines related to Health, Safety, and Environmental practices as applicable. - Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures. - Performs other duties assigned as needed. Qualifications - Minimum of a Bachelor’s degree and/or University degree is required. Advanced degree is preferred. Requirements - A minimum of four (4) years of experience in a related, professional environment. - Strong oral communication, presentation, project management, and prioritization skills. - Excellent interpersonal relationships. Preferred Qualifications - Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements, evidence generation, literature reviews, and/or Clinical Evaluation Report (CER) document creation. - Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting. - Previous experience in orthopedics, specifically joint reconstruction and/or spine. Other Requirements - May require up to 10% domestic and/or international travel to other locations and sites. - This is a remote position. Benefits - Base pay range: $109,000.00 - $174,800.00. - Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - Eligible to participate in the Company’s long-term incentive program. - Vacation: 120 hours per calendar year. - Sick time: 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents. - Holiday pay, including Floating Holidays: 13 days per calendar year. - Work, Personal and Family Time: up to 40 hours per calendar year. - Parental Leave: 480 hours within one year of the birth/adoption/foster care of a child. - Bereavement Leave: 240 hours for an immediate family member; 40 hours for an extended family member per calendar year. - Caregiver Leave: 80 hours in a 52-week rolling period. - Volunteer Leave: 32 hours per calendar year. - Military Spouse Time-Off: 80 hours per calendar year.

Role Description Ensures capture of discharge diagnosis and procedures independently. Documents the patient's clinical status and care provided. Performs concurrent review of patient records for documentation to support assignment of clinical codes. Key Responsibilities - Performs assessment of patient records to evaluate documentation for accuracy, legibility and completeness. - Works with coding staff to ensure documentation of discharge diagnoses, including any coexisting co-morbidities, and procedures are complete. - Communicates with providers regarding missing, unclear, or conflicting clinical documentation. - Collaborates with case managers, nursing staff, and other staff on documentation issues and resolves provider queries prior to patient discharge. - Monitors provider documentation queries for timely and compliant response and escalates issues. - The responsibilities listed are a general overview of the position and additional duties may be assigned. Technical Capabilities - Written Communication (Novice): Demonstrates the ability to write clear, detailed, and comprehensive status reports, memos and documentation. - Verbal Communication (Novice): Ability to enunciate clearly, using appropriate voice control and body language. - Medical Coding (Intermediate): The transformation of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes. - Critical Thinking (Novice): The objective analysis and evaluation of an issue in order to form a judgment. - Relationship Management: Manages internal and external organizational relationships with clients, vendors, partners and staff. Core Accountabilities - Organizational Impact: Independently delivers on objectives with understanding of how they impact the results of own area/team and other related teams. - Problem Solving/ Complexity of work: Utilizes multiple sources of data to analyze and resolve complex problems; may take a new perspective on existing solution. - Breadth of Knowledge: Has advanced knowledge within a professional area and basic knowledge across related areas. - Team Interaction: Acts as a "go-to" resource for colleagues with less experience; may lead small project teams. Core Capabilities - Supporting Colleagues: - Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance and gain knowledge in new areas. - Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships. - Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. - Delivering Excellent Services: - Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them. - Solves Complex Problems: Approaches problems from different angles; identifies new possibilities to interpret opportunities and develop concrete solutions. - Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. - Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly. - Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. - Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure. - Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area. - Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. - Fostering Innovation: - Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches. - Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges. - Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements. Position Qualifications - LIC-Registered Nurse - Licensure-Others - Relevant Work Experience: 3 years - Education: Graduate of an approved discipline specific program Benefits This role offers the opportunity to make a meaningful impact within Vanderbilt Health, supported by a comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth. Company Description Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.