Regulatory Affairs Manager, (Cybersecurity and Digital Health) Remote
5-7 years' experience working with software and cybersecurity in a regulated industry in regulatory affairs, quality or R&D. No matter your role at Baxter, your work makes a positive impact on people around the world. At Baxter, we are deeply connected by our mission. * Play a key role in driving process improvements to the Baxter quality system to ensure a state-of-the-art software, cybersecurity and digital health process. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. Responsible for establishing and implementing global regulatory affairs and lifecycle management activities associated with software, cybersecurity and digital health. * May represent Baxter interests in industry and working groups$80k-180k yearly12d ago
Position Summary:The Therapeutic Excellence Learning Designer creates learning solutions aligned to their Therapeutic Area (TA) of focus that builds workforce capability, accelerates talent, improves performance and/or mitigates risk through relevant continuous product and disease learning experiences for learners across the Enterprise.. The Designer uses business fluency, data driven insights, and design thinking to create scalable, learner-centric, business outcomes focused, innovative, inclusive, science-based high-level designs and learner journeys by persona and role. The designer is also accountable for detailed learning asset design across all learning methodologies and technologies including digital media. The designer is accountable for working closely with the Learning Developer and Vendor Partners to ensure asset development aligns to the blueprints, high level designs and learner journeys on which they are anchored. Additionally, the Learning Designer applies expert vendor management and oversees the alignment and quality of vendor-partner developed learning experiences. The Learning Experience Designer must develop and leverage trusted partnerships with team members, stakeholders, and subject matter experts to ensure speed, quality, and cost effectiveness of the learning they design.Responsibilities:Uses brand strategy, global learning strategy, and data driven insights to design scalable learning solutions in collaboration with the client facing Learning Consultant to ensure achievement of business goals.Creates high-level designs and learning journeys by persona and role that are scalable, learner-centric, business outcomes focused, innovative, inclusive, science-based Collaborates closely with the Therapeutic Excellence Learning Creation Lead, vendor partners, business aligned learning partners, and subject matter experts (SMEs) to design learning experiences aligned to brand priorities.Facilitates and leads content creation and experience design sessions, works to assess learner/persona skill gaps, and clearly defines instructional objectives for product and disease learning solutions.Leverages data driven insights to create Detailed Design Documents for learning content and assets for learner-centric multi-part learner journeys leveraging a deep understanding of therapeutic area and brand strategy to solve business challenges and achieve business outcomes.Creates any required content scripting leveraging a deep understanding of brand,therapeutic area acumen, learners, organizational culture, personas, mindset, and skills, and internal limits including change tolerance, leader availability, learner attention/absorption, tools/resources.Partners with Learning Developers, BPO talent, and vendors as they iterate and develop learning solutions and assets in accordance with the Detailed Design, ensuring assets are created in a way that can be scaled to additional audiences and needs, reducing redundant spend and work Oversees learning design and development vendors when work is outsourced to ensure alignment to standards, high-level design, defined learner experience and business outcomes.Participates in formal legal and medical review processes as required, ensuring successful review and timely delivery of compliant product and disease learning Works with Delivery point to support the certification of trainers as required.Core Capabilities:Therapeutic, Scientific and Business AcumenLearning Design and Development (i.e., assess, design, develop, & evaluate) CommunicationTeam collaboration Program management Change management Stakeholder management Vendor management Digital learning and learning management systems Required: Bachelor's degree in instructional design, learning technology, adult education, or other related discipline6 years of related experience (4 with master's degree)1 years of experience as a Learning Designer with experience leading the design and development of learning solutions to drive mindset, skill and behavior change to achieve business outcomes Up to date instructional design and learning science applied to live, virtual, online, social, adaptive and in the flow continuous learning experiences Use of innovative digital learning technologies and scalable user interfaces for web and mobile learning experiences Applies design thinking principles to assess and solve for learner/persona capability gaps Strong conceptualization, visual communication, and storyboarding ability Ability to create wireframes and visual design mock-ups Strong communication skills, verbal and written, for both technical and non-technical learning Co-creates, collaborates, and builds trusted partnerships with team and business stakeholders Leverages data driven insights to drive decisions Agility, flexibility, working in a fast-paced iterative environment Creative thinking, strong problem-solving, continuous improvement capability Ability to guide / mentor Learning Developers and troubleshoot issues Management of design and development vendors Assess capability, evaluate, and measure value and business impact Stakeholder analysis and management, change management Business acumen and ability to rapidly learn business and cultural contexts Preferred:Experience as a Learning Designer of dynamic learning solutions and role curriculum Pharmaceutical or healthcare industry experience, preferred experience in the development of therapeutic, scientific, or medical learning.Experience participating in formal compliance review processes Possesses a continuous learning mindset towards technology and finding new ways to improve the learner experience Experience as a Learning Designer supporting vaccine and or oncology products in a pharmaceutical environment Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.Who we are … We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.What we look for … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$97,680.00 - $153,700.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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N/A$97.7k-153.7k yearly3h ago
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* Work closely with product teams and enterprise business operations staff to maintain security governance documentation (Policies, Procedures, and Standards) for Baxter products and corporate IT processes The role will be instrumental in providing mentorship and reviews of security across all of the products across Baxter. No matter your role at Baxter, your work makes a positive impact on people around the world. Conduct internal security control assessments of Baxter product offerings (including physical device hardware and supporting IT infrastructure) using the Baxter Digital Security Control Framework and various third-party standards/frameworks, and coordinate post-assessment activities (leadership reporting, risk analysis/prioritization, and tracking of ongoing remediation actions) At Baxter, we are deeply connected by our mission. You will provide consulting and security mentorship on emerging threats, vulnerabilities, and security practices that may have an impact on the security posture of a variety of applications across the Baxter portfolio. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. This role will also support Baxter's commercial compliance work with SOC2, HITRUST, and related standards. As a key member of the Central Product Security Team, you will work closely with Baxter's global development teams and our US Government agency partners to lead security authorizations for Baxter's medical products. * Support annual audits for Baxter's commercial certifications (SOC2 and HITRUST) by facilitating audit walkthroughs/demonstrations, collecting and analyzing control implementation evidence, and collaborating closely with third-party auditors to lead audit logistics and provide feedback on reports/deliverables$68k-156k yearly5d ago