by Ronald Barron | May 13, 2024 | Uncategorized
About the Role
Title: Senior Analyst, Data Standards (Remote)
Location: CA-San Francisco
JobDescription:
Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Senior Data Standards Analyst within Clinical Data and Reporting Standards contributes to the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensuring AbbVie’s conformance to CDISC standards and industry best practices. This role will focus on CDASH and SDTM standards within therapeutic area(s) such as immunology, eye care, neuroscience, and medical aesthetics.
Standards Development responsibilities include:
- Actively participating with a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
- SDTM mapping
- Data Collection
- Data Review Rules
- Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
- ADaM mapping and derivation
- Study-level tables, listings, or figures
- Product-level safety analysis displays
- Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities.
- Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.)
- Educate the organization on the proper use of standards in pipeline activities.
- Communicate ongoing standard development activities across the organization.
Pipeline responsibilities may include:
- Create, review and provide feedback on SDTM Mapping Specifications and Trial Design Domains
- Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC
- Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions
- Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation
Other responsibilities include:
- Representing AbbVie’s interests in industry standards development projects,
- Staying current with industry standards such as CDISC, and the regulatory requirements related to their use
- Identifying improvements to the processes and content of standards, and driving those improvements to completion
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by Ronald Barron | May 10, 2024 | Uncategorized
About the Role
Title: Senior Manager, Website Operations
Location: Remote-Southeast Asia
JobDescription:
About Remote
Remote is solving global remote organizations biggest challenge: employing anyone anywhere compliantly. We make it possible for businesses big and small to employ a global team by handling global payroll, benefits, taxes, and compliance. Check out remote.com/how-it-works to learn more or if youre interested in adding to the mission, scroll down to apply now.
Please take a look at remote.com/handbook to learn more about our culture and what it is like to work here. Not only do we encourage folks from all ethnic groups, genders, sexuality, age and abilities to apply, but we prioritize a sense of belonging. You can check out independent reviews by other candidates on Glassdoor or look up the results of our candidate surveys to see how others feel about working and interviewing here.
All of our positions are fully remote. You do not have to relocate to join us!
What this job can offer you
The Marketing team is the engine that powers Remote’s expansion. Through product marketing, performance marketing, events, communications, campaigns, and content, our team tells the world about Remote to bring in revenue and establish Remote as the international leader in global HR and remote work.
Join Remote’s Content & SEO team as a Senior Manager, Website Operations. In this role, you will collaborate directly with the Director of Content & SEO to uphold and enhance the operational excellence of our website. As a key leader, you will strategically guide our website sprint processes, ensuring close collaboration with the growth engineering and design teams to execute our ambitious website roadmap effectively.
What you bring
- Experience: Extensive experience in managing complex website roadmaps, demonstrating a robust blend of creative insight and technical expertise.
- Leadership Skills: Proven leadership in managing web operations teams, fostering a culture of innovation and strategic thinking.
- Collaboration: Strong capability to lead and integrate efforts across diverse functional teams, ensuring that all perspectives are harnessed to achieve business objectives.
- Technical Knowledge: In-depth understanding of web architecture, advanced website management practices, and CMS platforms, with a preference for experience in Contentful.
- Communication: Exceptional communication skills, with the ability to convey complex web strategies in a clear and engaging manner.
- Project Management: Advanced project management skills, with a track record of delivering projects on time and within scope, managing both resources and timelines effectively.
- Background: Experience in fast-paced or startup environments highly regarded. Remote and asynchronous work experience is beneficial.
- Language: Fluency in English, both written and spoken.
Key Responsibilities
- Strategic Leadership: Direct the website sprint process, aligning website operations with broader company strategies and ensuring effective collaboration across technical and creative teams. Develop and maintain a forward-looking website strategy that prioritizes business goals, focusing on acquisition, conversion, and enhanced user experience.
- Team Management: Build and manage the website operations team, mentoring staff and scaling the team as needed to support business growth and complex projects.
- Roadmap Execution: Lead the continual development and execution of the website roadmap, ensuring projects are prioritized according to strategic business objectives and contribute effectively to user acquisition, engagement, and conversion.
- Quality Assurance: Maintain the highest standards for all website updates and modifications, ensuring consistency with brand guidelines and technical precision.
- Cross-Functional Leadership: Enhance team integration by working closely with content, SEO, development, and design teams, promoting a seamless fusion of content excellence and technical performance.
- Problem Solving: Rapidly address and resolve any operational challenges, maintaining superior website functionality and user experience.
- Advanced Project Management: Oversee complex projects, coordinating closely with project management staff and serving as a pivotal link among various departments to guarantee effective and timely delivery.
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by Ronald Barron | May 10, 2024 | Uncategorized
About the Role
Solutions Engineer
Remote
AcuityMD is a technology company that connects software and data to help MedTech companies of all sizes transform how they bring their products to market. Each year, the FDA approves ~6,000 new medical devices. By combining quality data and tailored workflows, our platform helps MedTech commercial teams get their devices into the hands of the health care providers who need them to improve patient care. Were backed by Benchmark, Redpoint, and Ajax Health and were on a mission to accelerate the adoption of cutting edge medical technologies.
As a Solution Engineer at AcuityMD, you will play a crucial role in driving the sales process by providing technical product expertise, presenting tailored solutions, and ensuring customer success. You will work closely with the Sales team to understand customer requirements and deliver compelling demonstrations of AcuityMD’s products. The Solution Engineer will use a consultative approach to understand business and technical requirements and recommend effective strategies for implementing AcuityMD solutions.
Team Mission
At AcuityMD, we aim to empower our solution engineers to be strategic partners to our customers and prospects. Our team is committed to developing and maintaining a deep understanding of AcuityMD’s products and services while staying current with the latest medical device industry trends. We strive to build and nurture long-term customer relationships by understanding their unique needs. Working closely with cross-functional teams, we collaborate to identify new opportunities, streamline processes, and enhance product offerings. We advocate for the value of data-driven insights, educating customers and prospects on how AcuityMD’s platform can transform their businesses. We embody the highest professional, ethical, and integrity standards in all interactions.
Responsibilities
- Engage with customers to understand their business challenges, technical landscape, and requirements.
- Develop and present tailored AcuityMD solutions that address customer needs and demonstrate the value of the company’s products and services.
- Collaborate with the Sales team to develop account strategies anddrivethe sales process.
- Deliver compelling product demonstrations, proofs of concept, and presentations to showcase the value of AcuityMD solutions.
- Respond to technical inquiries, RFIs, and RFPs with functional and technical solutions.
- Provide feedback to the Product, Engineering, and Marketing teams on customer needs, industry trends, and competitive landscape todriveproduct innovation and improvements.
- Participate in industry events, webinars, and conferences to build brand awareness and showcase AcuityMD’s capabilities.
- Work as a team player by contributing, learning, and sharing new knowledge.
- Up to 25% domestictravelrequired.
Your Profile
- 3+ years of experience in the IT industry, with a focus on pre-sales or technical sales roles, ideally in selling CRM, healthcare IT solutions, or high-value business solutions.
- Bachelor’sdegreein Engineering, Computer Science, or a related field, or equivalent relevant experience.
- Strong verbal and written communication skills with a focus on needs analysis, positioning, business justification, and closing techniques.
- Superior presentation and demonstration skills, with the ability to engage with both technical and non-technical audiences.
- Experience working with CRM platforms, healthcare IT systems, or other relevant enterprise SaaS applications.
- Prior experience collaborating with cross-functional teams, including sales, marketing, product management, engineering, and customer success.
- Self-motivated,flexible, and able to take initiative in a dynamic environment.
- Strong problem-solving skills and the ability to think creatively to develop innovative solutions for customer needs.
Nice to Haves
- Experience working in the MedTech or healthcare industry, with knowledge of industry regulations, standards, and best practices.
- Familiarity with data analytics, business intelligence tools, and data visualization techniques
- Knowledge of industry common data sources such as NPI, Medicare claims, PubMed, and ICD/CPT/HCPCS codes
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by Ronald Barron | May 10, 2024 | Uncategorized
About the Role
Title: Sr. Quality Systems Engineer – CAPA
Location: Remote, US
Job Description:
Boldly innovating to create trusted solutions that detect, predict, and prevent disease.
Discover your power to innovate while making a difference in patients’ lives.iRhythm is advancing cardiac careJoin Us Now!
At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythms employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.
About This Role
As the Sr. Quality Systems Engineer CAPA, you will be responsible for the maintenance of a robust global CAPA process across iRhythm. You will serve as one of the advocates for cross-functional collaboration, continuous improvement, and compliance, with the responsibility of driving excellent quality system CAPA process performance globally. This role will work closely with cross-functional CAPA owners to provide training, guidance, and review of CAPA investigations and phases. In this role, you will have the opportunity to impact product and process quality and regulatory compliance at iRhythm.
In iRhythms fast growing environment, you will have the opportunity to enhance your technical skills and leadership competencies and advance your career.
This role supports various U.S. and UK iRhythm sites and may require 15% travel.
Responsibilities:
- Ensure the CAPA system is compliant with U.S. and applicable international Medical Device standards and regulations.
- Work alongside CAPA owners and stakeholders on assessing issue descriptions and ensuring containment, root cause analysis, correction, corrective and preventive actions, and effectiveness checks are appropriate, of high quality, and timely
- Support CAPA Board meetings, drive decision-making through data, and follow through on outcomes.
- Train and mentor CAPA owners in all required elements and best practices of CAPA, including use of the CAPA tool.
- Support audit program during regulatory and internal audits as it relates to CAPA files and audit readiness.
- Maintain the quality and compliance of CAPA system records to ensure audit-readiness for internal and external quality system audits.
- Produce, analyze, and present trend metrics and reports and establish further actions as needed.
- Engage in continuous improvement of the CAPA program by identifying opportunities and recommending actions.
Required Qualifications:
- Bachelors Degree or the equivalent quality/regulatory experience
- Minimum of 5 years of experience in a Quality or Regulatory related role.
- Minimum of 2 years of experience with Corrective Action and Preventative Action activities, within a medical device or equivalent healthcare company.
- Must have a deep understanding of corrective and preventive actions systems and associated regulatory requirements.
- Previous experience in a medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD/MDR
- Strong investigational and problem-solving skills
- Must build rapport across functional teams within the organization and have the ability to work comfortably at all levels within the organization
- Attention to detail and timeliness are critical
- Excellent communication (verbal and written) and interpersonal skills required
- Basic statistical methods including trend analysis
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by Ronald Barron | May 10, 2024 | Uncategorized
About the Role
Project Manager
Remote
About the job
Working closely and cross-functionally within the Merkle | Cardinal Path Team. The Project Manager plays a pivotal role in helping to deliver digital media and analytics services.
This position requires the ability to supervise multiple projects and requires a general technical background, strong business knowledge and very strong project management skills. The Project Manager should be driven to improve processes within the organization.
As part of the Merkle | Cardinal Path team, our Project Managers have the opportunity to work across high-tech projects of varied complexity, delivering work that helps brands to leverage data to achieve their goals.
Responsibilities include:
- You will development and tracking of integrated project plans. Adapts and applies the delivery approach to meet project objectives and client business drivers. Establishes and maintains project communications.
- You’ll oversee project estimations. Oversees the development of project deliverables. Establishes and maintains processes to manage scope throughout the project lifecycle.
- Champions project management best practices across the organization:
- Establishes standard reports for project teams and clients.
- Establishes PM procedures for project teams including project start, execution, completion, and review.
- Provides an infrastructure of constant health performance monitoring.
- Ability to prioritize project deliverables and incident handling across the organization.
- Self-motivated and ability to work independently in meetings deadlines.
- This is a client-facing role. As many of our clients are in the Eastern, Pacific, or Central time zone, candidates will need to be available during AST, EST, PT or CST hours.
Qualifications
- 3-5 years’ experience in digital media/marketing/analysis in a project manager or account manager role
- Bachelor’s degree in Business, or a diploma in marketing and/or project management
- Experience delivering digital media, technology and analytics projects within an agency environment.
- Some familiarity with website analytics (Google Analytics, Omniture, Coremetrics, etc) would be considered an asset.
- Knowledge of OpenAir or NetSuite would be considered an asset.
- Ability to prioritize project deliverables and incident handling across the organization.
- Self-motivated and ability to work independently in meeting deadlines.
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