Current jobs related to Senior Manager, Global Scientific and Regulatory Documentation - Minneapolis - Bristol-Myers Squibb
-
Senior Product Manager, Competitive Intelligence
1 month ago
Minneapolis, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools,...
-
Senior Product Manager, Competitive Intelligence
1 month ago
Minneapolis, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...
-
Principal Regulatory Affairs Specialist
1 month ago
Minneapolis, United States Boston Scientific Gruppe Full timeAbout the role: The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment spaces. Additionally, the Associate is responsible for representing...
-
Regulatory Affairs Associate II
2 weeks ago
Minneapolis, Minnesota, United States Boston Scientific Gruppe Full timeAbout Boston Scientific Gruppe:At Boston Scientific, we are dedicated to enhancing lives through innovative medical solutions. Our advanced products and technologies play a crucial role in diagnosing and treating a variety of medical conditions. We are committed to continuous innovation in key areas and expanding our reach into new markets.In the Rhythm...
-
Global Regulatory Affairs Expert
6 days ago
Minneapolis, Minnesota, United States Inspire Medical Systems I Full timeCompany OverviewINSPIRE MEDICAL SYSTEMSInspire Medical Systems is at the forefront of the medical industry, focused on improving the lives of individuals affected by Obstructive Sleep Apnea (OSA). Our groundbreaking FDA-approved device is designed to reduce the severity of OSA for those who have not found consistent relief through CPAP therapy. We are...
-
Regulatory Affairs Associate II
2 weeks ago
Minneapolis, Minnesota, United States Boston Scientific Gruppe Full timeAbout Us:At Boston Scientific Gruppe, we are dedicated to enhancing lives through innovative medical solutions. Our advanced products and technologies play a crucial role in diagnosing and treating a variety of medical conditions. We are committed to continuous innovation in key sectors and expanding our reach into emerging markets.In the field of Rhythm...
-
Global Regulatory Affairs Expert
5 days ago
Minneapolis, Minnesota, United States Inspire Medical Systems I Full timeCompany OverviewINSPIRE MEDICAL SYSTEMSInspire Medical Systems is at the forefront of medical innovation, focusing on improving the lives of individuals dealing with Obstructive Sleep Apnea (OSA). Our cutting-edge FDA-approved device is designed to reduce the severity of OSA for those who find limited success with traditional CPAP therapy. We are dedicated...
-
Global Regulatory Affairs Expert
1 week ago
Minneapolis, Minnesota, United States Inspire Medical Systems I Full timeCompany OverviewINSPIRE MEDICAL SYSTEMSInspire Medical Systems stands at the forefront of the medical industry, committed to improving the lives of individuals affected by Obstructive Sleep Apnea (OSA). Our groundbreaking FDA-approved device is designed to reduce the severity of OSA for those who find limited success with traditional CPAP therapy. We...
-
Minneapolis, United States Thermo Fisher Scientific Full timeWork Schedule Other Environmental Conditions Office Job Description Job Title: Senior Account Manager - Visualization and Data Solutions Location: ND, SD, NE, KS, MN, IA, MO, WI, IL, IN, MI What will you do? The Visualization and Data Solutions (VDS) business for Electron Microscopy provides software applications for microscopy image processing and analysis...
-
Senior System Engineer – Medical Products
4 days ago
Minneapolis, United States Quest Global Full timeJob Requirements Quest Global is an organization at the forefront of innovation and one of the world's fastest growing engineering services firms with deep domain knowledge and recognized expertise in the top OEMs across seven industries. We are a twenty-five-year-old company on a journey to becoming a centenary one, driven by aspiration, hunger and...
-
Professional Education Training Manager
1 month ago
Minneapolis, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools,...
-
Senior Clinical Research Manager
1 month ago
Minneapolis, Minnesota, United States MED Medtronic Inc Full timeSenior Clinical Research Manager - Cardiac Ablation SolutionsApplyremote typeRemotelocationsMinneapolis, Minnesota, United States of Americatime typeFull timeposted onPosted Yesterdayjob requisition idR1301At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...
-
Regulatory Affairs Specialist II
2 weeks ago
Minneapolis, Minnesota, United States Mlnneapolis heart institute foundation Full timeThe Minneapolis Heart Institute Foundation (MHIF) is on the lookout for a dedicated Quality & Regulatory Affairs Specialist II to help advance MHIF's mission of eradicating heart and vascular diseases. Our commitment is to enhance cardiovascular health through pioneering research and educational initiatives. With over four decades of experience, MHIF stands...
-
Minneapolis, Minnesota, United States Boston Scientific Gruppe Full timeJob SummaryBoston Scientific Gruppe is a global leader in medical science, committed to solving the challenges that matter most and transforming lives through innovative medical solutions.This role offers a unique opportunity to work in a dynamic team, leading evidence strategy, execution, and communication of HEOR projects for the BSC Neuromodulation...
-
PFAS Senior Managing Consultant
3 months ago
Minneapolis, United States Ramboll US Corporation Full timeCompany Description Ramboll is a global multi-disciplinary engineering, design, and consultancy company. We have 16,500 employees worldwide, with 300 offices across 35 countries, including 59 offices in the US. Joining Ramboll means working for a company that strives to make a difference - for our employees, clients, and society. We truly support and...
-
Education and Training Program Manager
2 weeks ago
Minneapolis, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we provide an opportunity to leverage your potential by collaborating with a diverse team of high-achieving professionals, addressing some of the most significant challenges in the healthcare sector. With access to...
-
Minneapolis, Minnesota, United States Boston Scientific Full timeAbout Boston Scientific:Boston Scientific is a global leader in medical science dedicated to improving patient health and advancing science for life. With a deep caring for human life, we are committed to transforming lives through innovative medical solutions that create value for our customers and support our employees and communities. Our mission is to...
-
Senior Manager
3 months ago
Minneapolis, United States RBC Capital Markets, LLC Full timeJob Summary Job Description What is the opportunity? The Senior Manager - Economic Sanctions supports RBC's US Economic Sanctions Program by providing subject matter expertise related to clients, products, securities, and guidance on sanctions regulatory risk from a US perspective. This position is located in RBC's Minneapolis office reporting to the...
-
Professional Education Specialist III
4 weeks ago
Minneapolis, Minnesota, United States Boston Scientific Full timeAdditional Location(s):US-MN-Arden Hills; US-MN-Maple Grove; US-MN-MinneapolisDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health...
-
Senior Regulatory Affairs Specialist
2 months ago
Minneapolis, United States Laborie Medical Technologies Corp Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an...
Senior Manager, Global Scientific and Regulatory Documentation
1 month ago
Senior Manager, Global Scientific and Regulatory Documentation Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Position Summary To coordinate and author complex documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members. Key Responsibilities Authors complex clinical documents [eg, Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries] for timely submission to health authorities worldwide according to: good documentation principles (organization, clarity, scientific standards) consistency between text and tabular presentations or graphical displays in compliance with BMS documentation standards and worldwide regulatory requirements Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents. Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects. Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure: optimal communication between authoring team and development team members coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation timely completion and high quality of assigned documents Review and edit documents as required. Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards. Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship. Qualifications & Experience PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 5-10 years of pharmaceutical regulatory documentation experience. Demonstrated strong writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans). Demonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines. Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions. Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team. Working knowledge of a document management system and basic knowledge of the document publishing process. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. #J-18808-Ljbffr
