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A critical component of the export control program is to work collaboratively with the Vice Provost for International Affairs; Office of Technology Licensing, Environmental Health & Safety, Office of the General Counsel, and the Office of Finance & Treasury.
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Ensures appropriate controls are in place to meet regulatory requirements (i.e. J-sox, Third Party Risk Management, etc.) Ensure the adoption and enforcement of all flexible workforce policies, which includes, working closely with Legal Affairs and other internal stakeholders.
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Partner with Product teams, Client Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value for Client Global Regulatory Affairs.
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Participate in the development of the CMC regulatory strategy for biologics submissions.
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Develop and implement strategic MSL field/territory plans and objectives in alignment with Medical Affairs and product strategy and oversee the successful execution of these plans. Director, North America Oncology Medical Science Liaison Team is a field-based position within the Medical Affairs Department.
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Ensure proper execution of technical controls associated with regulatory compliance programs including NERC CIP, SOX, BPU and FERC Affiliate Restrictions. The position will monitor and assure technical controls associated with various regulatory compliance programs are properly executed, including the supervision of contractor personnel responsible for performing compliance tasks.
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Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Collaborates with cross-functional teams, including operations, quality assurance, regulatory affairs, and finance, to align capital projects with business objectives and regulatory requirements.
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Genmab is looking for a (Senior) System Manager to help us maintain, develop, and operate our enterprise electronic document management system (EDMS), GenDocs, covering the clinical development, regulatory affairs, CMC, and QA areas in R&D.
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3 years in the pharmaceutical industry, preferably with 1 year CMC regulatory experience. Experience with CMC regulatory documents (IND/CTAs, BLAs, MAAs, responses and variations). Experience in developing CMC regulatory strategy.
$85.5 - $87.07 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Manager-Publications is expected to develop and utilize a network of internal relationships with local and global publication stakeholders, including colleagues from Medical Affairs, Clinical Data Science & Evidence, legal, regulatory affairs, global publication team, and commercial publications colleagues from market access and marketing.
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We have four main divisions within AH - a full-service Association Management Company; a Marketing and Communications Agency (MarCom); a Meetings & Events Management Team; and a division that focuses on other custom solutions such as strategic planning, website builds, database integrations, accounting services, staff recruitment, credentialing management, public affairs and lobbying, and growing non-dues revenue.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
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Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work.
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Strong and dependable leader who acts with humility and builds trust with management and across all stakeholders and cross functional groups including medical affairs, customer engagement, market access, sales, sales training, finance, legal, regulatory and compliance teams.
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regulatory affairs jobs Title: sr regulatory associate Company: Thermo Fisher Scientific in Lawrence, NJ
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