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Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. How you'll make an impact: Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams Review and interpret study data analyses Contribute to the generation of product life cycle plans (e.g., post-market surveillance). What you'll need (Required): Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria Demonstrated track record in people management or equivalent work experience based on Edwards criteria What else we look for (Preferred): Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria Medical writing or regulatory certification or equivalent work experience based on Edwards criteria Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria Experience working in a regulated industry or equivalent work experience based on Edwards criteria Certification in related fields Strong leadership in project and team management, including coaching and performance oversight. Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. Familiarity with coronary interventional and structural heart environments. Proven ability to develop metrics demonstrating medical writing value to the business. Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

At Freddie Mac, our mission of Making Home Possible is what motivates us, and it's at the core of everything we do. Since our charter in 1970, we have made home possible for more than 90 million families across the country. Join an organization where your work contributes to a greater purpose. Position Overview: Freddie Mac's Quality Control Department is seeking an accomplished professional with technical proficiency and a keen attention to detail to join us as a Quality Control Credit Risk Policy Professional. The ideal candidate will infuse energy and innovative thinking to overcome challenges in a fast-paced, dynamic environment. If you are eager to explore business value through collaborative tools, we encourage you to apply and become part of a team committed to ensuring quality. As a member of the QC Policy team in the Credit Risk Policy Professional role, you will engage in a variety of tasks, such as supporting the review of policies and procedures to ensure their appropriateness and adequacy, assisting in process mapping initiatives, and contributing to the creation of visuals and job aids to simplify complex activities. The preferred candidate should possess a strong aptitude for analyzing data and summarizing intricate information, collaborating effectively with diverse teams, producing clear and user-friendly documentation, and customizing SharePoint pages to optimize user experience. Our Impact: The QC Policy team is responsible for producing policies and procedures, job aids and other resources to teams within Quality Control, such as Underwriting Operations which conducts quality control reviews of loans purchased by Freddie Mac to ensure that the loans purchased by Freddie Mac meet the terms of business under which they were delivered. Your Impact: As part of the QC Policy team, you will create job aids and other written documentation utilized by the QC Underwriting team to ensure resources are accurate, clear, and equip our underwriters to deliver a consistent experience in alignment with the Freddie Mac Selling Guide. You will also develop or update resources for various teams within QC which support the Underwriting team, providing cross-functional direction where roles and responsibilities connect. Your daily responsibilities will include: Participate in the creation and updating of Quality Control documentation, including job aids, tools, and procedures. Efficiently manage and maintain SharePoint sites for various teams within Quality Control. Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Facilitate knowledge sharing sessions with subject matter experts and stakeholders across Single Family Quality Control by scheduling sessions, creating agendas, scribing meeting minutes and outlining action items and next steps, and following up to ensure next steps are executed. Qualifications: Typically has minimum of 2 - 4 years related experience in professional technical writing. Experience in the mortgage industry, including exposure or understanding of managing credit risk and familiarity with Freddie Mac Selling Guide. Ability to manage multiple projects within minimal supervision. Moderate to strong technical proficiency with MS Office, specifically Word and Excel, Adobe Acrobat and other databases. Intermediate knowledge of SharePoint is preferred, including familiarity with SharePoint architecture, experience creating lists and document/form libraries, and utilizing web parts. College Degree or equivalent work experience. Keys to Success in this Role: An extraordinary attention to detail. Quick to learn new technologies and tools, with the ability to provide technical guidance to the team. Strong written communication skills, capable of explaining concepts or new/updated processes clearly in writing. Ability to logically organize content. Exceptional reading comprehension with the ability to identify inconsistencies or gaps in documentation. Robust analytical and quantitative skills are essential. Capability to emulate the team's communication style to ensure consistency in terminology, tone, composition, and formatting across documentation. Comfortable interacting with internal management and partners within Freddie Mac. Strong problem-solving and critical thinking skills. Highly organized, with the ability to manage multiple assignments simultaneously and meet timelines, working independently without the need for significant guidance. Current Freddie Mac employees please apply through the internal career site. We consider all applicants for all positions without regard to gender, race, color, religion, national origin, age, marital status, veteran status, sexual orientation, gender identity/expression, physical and mental disability, pregnancy, ethnicity, genetic information or any other protected categories under applicable federal, state or local laws. We will ensure that individuals are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. A safe and secure environment is critical to Freddie Mac's business. This includes employee commitment to our acceptable use policy, applying a vigilance-first approach to work, supporting regulatory mandates, and using best practices to protect Freddie Mac from potential threats and risk. Employees exercise this responsibility by executing against policies and procedures and adhering to privacy & security obligations as required via training programs. CA Applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Notice to External Search Firms: Freddie Mac partners with BountyJobs for contingency search business through outside firms. Resumes received outside the BountyJobs system will be considered unsolicited and Freddie Mac will not be obligated to pay a placement fee. If interested in learning more, please visit www.BountyJobs.com and register with our referral code: MAC. Time-type:Full time FLSA Status:Non-Exempt Freddie Mac offers a comprehensive total rewards package to include competitive compensation and market-leading benefit programs. Information on these benefit programs is available on our Careers site. This position has an annualized market-based salary range of $85,000 - $127,000 and is eligible to participate in the annual incentive program. The final salary offered will generally fall within this range and is dependent on various factors including but not limited to the responsibilities of the position, experience, skill set, internal pay equity and other relevant qualifications of the applicant.