Senior Consultant jobs in United States, Minnesota, Minnetonka

Your responsibilities will include:

• Generates analysis datasets, statistical summary tables, listings, figures, and reports primarily using SAS.
• Extracts clinical data from a variety of databases and converts to SAS format.
• Performs quality control checks of SAS programs.
• Develops programming standards, templates, and macros in collaboration with Statistical Programming group.
• Compiles clinical data, statistical summary tables, listings, and figures, and presents these results to the
• Biostatistician and internal clinical teams for review.
• Assists with template development and contributes to statistical analysis plans under the direction of the Biostatistician.
• Researches and applies statistical procedures and methods as needed.

Required qualifications:

• Bachelor’s Degree in statistics or related field or equivalent experience required
• Minimum five years of statistical programming experience using SAS to analyze clinical study data.

Preferred qualifications:

• Master’s Degree in statistics or related field preferred
• Experience with Snowflake and Medidata RAVE preferred
• Prior experience in Urology preferred
• Proven knowledge of FDA CFR Part 11 compliance and clinical study processes.
• Excellent interpersonal communication and project coordination skills with demonstrated ability to effectively interface with internal and external customers.
  

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

About the role:

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Marlborough, MA, or Arden Hills, Maple Grove or Minnetonka, MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:

• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and MDR CE mark submissions
• Develops and implements regulatory strategies for new and modified products
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance and advises on the impact of such regulations
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Tracks timelines and documents milestone achievements for inclusion in regulatory submissions
• Interacts with regulatory agencies as part of submission review and on-site audit support
• Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes
• Trains to departmental and divisional policies and procedures
• Fosters a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility

Required qualifications:

• A minimum of a Bachelor’s degree, preferably in a scientific or technical discipline
• A minimum of 4 years work experience in Regulatory Affairs or a related discipline (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in medical devices or drugs
• Demonstrated knowledge of FDA, EU and/or international regulations
• Demonstrated experience supporting product development and sustaining activities
• Prior experience with a variety of submission types (DeNovo, 510(k), PMA, EU MDR)
• Experience of regulations applicable to the conduct of clinical trials
• Demonstrated understanding of product development process and design controls
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)

Preferred qualifications:

• Medical electrical equipment (MEE) experience
• Implantable medical device experience
• Ability to manage several projects simultaneously
• Effective research and analytical skills
• Excellent written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

About the role:
The Senior Clinical Safety Specialist manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring and ensuring execution of project-specific safety plans as well as overseeing event and complaint processing in accordance with study-specific operational plans.

This is a hybrid position (in office minimum three days per week) with the flexibility to be in Maple Grove, MN or Marlborough, MA or Valencia, CA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:
⦁ Manage adverse event processing including report review, safety query management, and expedited reporting

⦁ Assess type/level of processing to be done for adverse events

⦁ Minimum bachelor’s degree or equivalent experience
⦁ Minimum 5 years clinical trial experience within role of safety
⦁ Proven or prior experience with clinical trial safety

⦁ Therapeutic knowledge in Urology
⦁ Knowledge of GCP
⦁ Experience with processing and assessing safety events and medical narrative writing
⦁ Clinical database and systems

Maximum Salary: $ 152200

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Key Responsibilities:

• Support the development of the overall digital strategy, including CRM (email, text), web, SEO/SEM, and other key digital channels, in alignment with the broader Customer Engagement and Activation (CE&A) team to ensure an integrated marketing campaign strategy and activation.
• Lead projects encompassing the planning, execution, and measurement of digital campaigns targeting key audiences.
• Contribute to journey mapping exercises with cross-functional teams, developing tactical integrated communication plans that align with the customer journey.
• Partner with analytics resources to demonstrate the value of campaigns and provide a consistent cadence of performance reports.
• Regularly monitor analytics for campaigns and digital channels, collaborating with corporate and division analytics teams to create measurement plans and deliver insightful campaign reports to key stakeholders and leadership.
• Manage multiple programs simultaneously, effectively prioritizing work to contribute to the digital strategy while owning activation, execution, and implementation.
• Influence various functions and levels within the organization through strong interpersonal communication, written, and presentation skills.
• Proactively communicate and present fresh, innovative, and relevant ideas and plans to business partners, securing alignment and buy-in.
• Collaborate closely with key stakeholders, including:
  • Content Strategists to leverage provided content as part of broader communication efforts and offer best practices for content development and deployment to optimize customer experiences.
  • Social Media Strategists on all social strategies and tactics.
  • Paid Media Partners and External Agencies on the implementation and tracking of key campaigns.
  • Digital Production Teams and External Vendors on project planning and execution of digital deliverables.
  • Product Marketing, Omnichannel Marketing, and Global Integrated Communications Teams to ensure digital plans and tactics align with broader commercial marketing strategies.

Required Qualifications:

• Bachelor’s degree in a relevant field, with a strong preference for marketing.
• Minimum of 3 years of experience in marketing, communications, and/or digital marketing within a B2C or B2B environment.
• Demonstrated expertise in digital marketing, with a proven track record of developing and executing successful digital campaigns and programs.
• Proficiency in Google Analytics and data visualization tools such as Tableau.
• Comprehensive understanding of inbound and outbound email marketing, organic and paid search engine marketing, social media marketing, content marketing, website strategy, customer relationship management, webcasts/webinars, and related digital marketing strategies.
• Ability to work effectively as part of a regionally diverse team in a fast-paced environment.
• Willingness to travel up to 10% based on business needs.
• Availability for travel and overtime as required by business commitments.

Preferred Qualifications:

• MBA or advanced degree in a related field.
• Experience with Salesforce and Salesforce Marketing tools, including Marketing Cloud, as well as Adobe Experience Manager.
• Ability to challenge the status quo and identify opportunities for innovation.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for
exempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.