- Olympus Corporation of the Americas (Westborough, MA)
- …the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements and ... with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will ... + BS or comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports ... connected software systems. As needed provide input to define global regulatory strategy requirements. + Participate in...or auditor inquiries as directed. + Interface with International Regulatory Affairs Team and drive preparation of… more
- Parexel (Columbia, SC)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... Join us as a ** Global Labeling Operations Manager ** , where...years of biotech/pharma industry experience, including 2+ years in labeling/ regulatory operations with global responsibility. - Experience… more
- CSL Behring (Waltham, MA)
- **Position Title:** Senior Manager , Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager , Corporate and External Affairs , ... partners. + Act as a supporting partner to the regulatory policy team providing input on advocacy opportunities, and...in Pharmaceutical or life sciences company. + Experienced Corporate Affairs professional operating in a global environment… more
- Lundbeck (Deerfield, IL)
- Senior Director Medical Affairs , Movement Disorders Requisition ID: 7172 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With...Director and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the… more
- CSL Behring (King Of Prussia, PA)
- … or communications in the life sciences industry. + Experience managing Corporate Affairs in a global environment + Understanding of corporate social ... Associate Director, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Associate Director,...and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities,… more
- Parexel (Bismarck, ND)
- If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from ... dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely… more
- CSL Behring (King Of Prussia, PA)
- …delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other ... Regulatory CMC. + Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements. The Global Vice President QARA Compliance is ... internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates...recommendations. + Coordinates and leads audit activities with all global regulatory agencies (eg FDA, Notified Bodies,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for driving timely ... management deliverables supporting the Olympus portfolio. The Sr. Clinical Data Manager designs, develops, and maintains key data management deliverables used to… more
- BeOne Medicines (Emeryville, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... study progress in the region to senior management and Global Clinical Study Manager as required +...region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- … workforce is bound by our common values: **Job Summary:** The Senior Manager , Medical Affairs Training is responsible for designing, implementing, and managing ... The ideal candidate will have a strong background in medical affairs , adult learning principles, field-based medical roles, field reimbursement, compliance and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …roles and responsibilities of Quality Assurance. + Practical understanding of global regulatory /quality standards and requirements. + Potential for travel ... by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) more
- CSL Behring (King Of Prussia, PA)
- …the guidance of the Publications Director, you will partner with Medical Affairs leaders, Compliance, Clinical, HEOR, and other functions to build efficient ... SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication...provide first line support for junior team members (eg manager and sr manager ) + Lead operational… more
- Organon & Co. (Jersey City, NJ)
- …of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... We are looking for an experienced Associate Director, Program Manager to join our team. This successful candidate will...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Endo International (St. Louis, MO)
- …Teams **RELATIONSHIP WITH OTHERS:** Reports to the Sr Director, Quality and Regulatory Affairs . Manages group of exempt direct reports. Develops strategic ... develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering… more
- Olympus Corporation of the Americas (Westborough, MA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Other… more
- Olympus Corporation of the Americas (Westborough, MA)
- …deliverables from assigned projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials for various ... Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs , etc. + Independent organizational and time management skills… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... an integral role in the day-to-day functioning of the global medical safety organization. In this vital role you...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**… more
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