Current jobs related to Manager / Associate Director, Regulatory Affairs, Advertising & Promo Compliance (Hybrid) - Groton - BioCT Innovation Commons
-
Regulatory Compliance Expert
2 weeks ago
Groton, Connecticut, United States Precision Castparts Corp Full timeJob DescriptionJob Title: Export Compliance SpecialistCompany: Precision Castparts CorpJob Summary:We are seeking a highly skilled Export Compliance Specialist to join our team. As a key member of our compliance team, you will be responsible for establishing and maintaining robust trade compliance programs that meet export regulatory requirements and support...
-
Manager, Global Regulatory Strategy for Oncology
1 month ago
Groton, United States Pfizer Full timeWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
Manager, Global Regulatory Strategy for Oncology
1 month ago
Groton, United States Pfizer Full timeWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
Groton, Connecticut, United States Pfizer Belgium Full timeAbout the RoleWe are seeking a highly skilled and experienced Digital Innovation Director to join our Oncology Medical Affairs team at Pfizer Belgium. As a key member of our team, you will be responsible for leading the development and implementation of digital innovation strategies to drive business growth and improve patient outcomes.Key...
-
Quality and Compliance Standards Lead
2 months ago
Groton, United States Pfizer Full timeROLE SUMMARY The Quality Compliance Lead(s) (QCL) are key members of the Evidence Generation Team and are aligned by Therapeutic Area (TA). The QCL are responsible for supporting the quality oversight for implementation of research and studies conducted in the global Evidence Generation Platform. This role will coordinate and facilitate quality and...
-
Quality Assurance and Compliance Lead
2 days ago
Groton, Massachusetts, United States Pfizer Full timeJob Title: Quality Assurance and Compliance LeadThe Quality Assurance and Compliance Lead will play a critical role in ensuring the quality and compliance of our research and studies conducted in the global Evidence Generation Platform. This position will coordinate and facilitate quality and training activities cross-functionally for the BU related to...
-
Quality Assurance and Compliance Lead
7 days ago
Groton, Massachusetts, United States Pfizer Full timeJob SummaryThe Quality Compliance Lead will play a key role in ensuring the quality and compliance of research and studies conducted in the global Evidence Generation Platform. This role will coordinate and facilitate quality and training activities cross-functionally for the Business Unit related to Evidence Generation study activities.Key...
-
Medical Director, Breast Cancer
6 days ago
Groton, United States Pfizer Full timeJob Description ROLE SUMMARY Provide leadership in Breast Cancer Franchise on behalf of Asset Medical Affairs team. Provides strategic medical input for assets in collaboration with extended medical team and cross functional colleagues to support aligned objectives Collaborates with Brand partners in developing product strategy and ensures...
-
Export Compliance Specialist
7 days ago
Groton, Connecticut, United States Precision Castparts Corp Full time{"title": "Export Compliance Specialist", "description": "Job SummaryThis role is a key member of the compliance team for the Groton, CT and Tilton, NH sites, supporting the Facility Compliance Officer (FCO) in establishing and maintaining robust trade compliance programs that meet export regulatory requirements and day-to-day operational needs of the...
-
Export Compliance Specialist
2 months ago
Groton, United States Precision Castparts Corp Full timeThis position is a key member of the compliance team for the Groton, CT and Tilton, NH sites and will support the Facility Compliance Officer (FCO) with establishing and maintaining robust trade compliance programs that meet export regulatory requirements and support the day-to-day operational needs of the business. They will also serve as a key point of...
-
Export Compliance Specialist
2 months ago
Groton, United States Precision Castparts Corp Full timeCountry United States of America State / County Connecticut City Groton Division Structurals Company Groton Function Operations Workplace Type On-Site ...
-
Radiation Safety Compliance Specialist
4 weeks ago
Groton, Connecticut, United States General Dynamics Electric Boat Full timePosition Overview:The selected candidate will assume the role of Radiation Safety Compliance Specialist, reporting directly to the Industrial Radiation Safety Officer (RSO). This position plays a critical role in ensuring adherence to regulations set forth by the U.S. Nuclear Regulatory Commission (NRC) and the Rhode Island Department of Health (RIDOH)...
-
Director, Identity Governance
2 weeks ago
Groton, United States Pfizer Full timeWhy Patients Need You Technology impacts everything we do. Pfizer's digital and 'data first' strategy focuses on implementing impactful and innovative technology solutions across all functions from research to manufacturing. Whether you are digitizing drug discovery and development, identifying solutions, or making our work easier and faster, you will be...
-
Retail Lending
5 months ago
Groton, United States Chelsea Groton Bank Full timeJob DescriptionJob DescriptionOVERVIEW:Develops and originates all residential loan production in conformance with the Banks policies and procedures.PRIMARY ACCOUNTABILITIES / RESPONSIBILITIES:Performs any functions necessary, within scope of authority and expertise, to provide the highest level of service and responsiveness to customers.Originates...
-
Radiation Safety Compliance Specialist
4 weeks ago
Groton, Connecticut, United States General Dynamics Full timeResponsibilities for this PositionRadiation Safety Compliance SpecialistJob ID:Type: Full-Time# of Openings: 2Category: Environmental, Health & SafetyOverviewThe selected candidate will act as the Radiation Safety Compliance Specialist, reporting directly to the Industrial Radiation Safety Officer. This role is essential in ensuring adherence to the...
-
Groton, United States Pfizer, S.A. de C.V Full timeDirector, Project Management Office, Clinical Data Sciences United States - New York - Pearl River United States - Connecticut - Groton United States - Pennsylvania - Collegeville United States - New York - New York City Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling...
-
Retail Banking- Retail Branch Management Trainee
2 months ago
Groton, United States Chelsea Groton Bank Full timeJob DescriptionJob DescriptionRETAIL BRANCH MANAGEMENT TRAINEE (NE9)WHAT MANAGEMENT TRAINEES CAN EXPECT:This position is a retail branch management trainee position with a defined professional development program that includes both instructor-led and self-paced learning as well as hands on experiences in a retail branch. During a 12 month on the job paid...
-
Customer Solutions Assistant Manager
2 weeks ago
Groton, Connecticut, United States Chelsea Groton Bank Full timeJob DescriptionThis position is responsible for helping customers achieve their financial goals, small or large, by providing outstanding service in a courteous, professional and ethical manner. Whether processing day-to-day banking transactions or educating customers on bank services that enhance their financial well-being, customer solutions assistant...
-
Associate Direct Support Manager
2 months ago
Groton, United States Mosaic Full timeHourly Rate: $19.46 Per Hour If making a positive impact in the lives of others is always on your to-do list - you'll LOVE working with a team that puts people first. We're looking for an Associate Direct Support Manager to join our team! The Associate Direct Support Manager plays a key role in managing the operations of the Residential and Day...
-
Renewable Energy Project Manager
2 weeks ago
Groton, Connecticut, United States Nimbus Power Systems Full timeJob SummaryNimbus Power Systems is seeking a highly skilled and experienced Project Manager to lead the development of our next-generation fuel cell engine designs for heavy-duty applications. As a key member of our team, you will be responsible for ensuring the successful planning, execution, and completion of projects related to the development of hydrogen...
Manager / Associate Director, Regulatory Affairs, Advertising & Promo Compliance (Hybrid)
4 months ago
Description
Review promotional claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for consistency with product labeling.
Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications.
Review scientific exchange communications that require HPRC approval to ensure they are free from graphics and text representations that imply product promotion.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
Review and approval of promotional communications for conformance to product labeling and regulations related to Rx drug promotion. Reviews reflect appropriate risk assessments.
Knowledge and understanding of drug development, including phases of clinical studies, general requirements for drug marketing approval and basic statistics.
Knowledge and adoption of Accountability, Agility and Intrapreneurship within HPRC through seeking opportunities by which to improve HPRC processes or the quality of promotional materials for BI Rx drugs.
Knowledgeable of the FDCA and its implementing regulations in 21 CFR. Identify and routinely monitor reliable sources from which to obtain product and/or regulatory information.
Review and signature of FDA forms 2253 with approved promotional communications.
Requirements
Bachelors degree in life science or degree in the legal field (e.g., lawyer, para-legal) from an accredited institution.
Advanced degree preferred.
Persons with a non-science degree having relevant professional experience may be considered.
Associate Director level: must have three to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs.
Manager level: must have (1-3) years of experience in the pharmaceutical industry, preferably in Regulatory or Medical Affairs.
Specific experience in regulatory advertising and promotion is preferred.
Work history of successful participation of deliverables within a team matrix.
Persons in this role must have excellent communication skills both verbal and written.
All roles in US regulatory advertising and promotion require complete fluency in the English language as word choices and phraseology are particularly important in Rx drug promotion.
Must have knowledge of drug development process and ability to assess biostatistics and clinical studies with respect to the support of clinical claims.
Must have excellent written and verbal skills as the role will be required to interact with and influence other disciplines involved in BI promotion review.
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Compensation
This position offers a base salary typically between $111,000 and $232,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
#J-18808-Ljbffr