Director, Omnichannel - Global Oncology Medical Affairs Daiichi Sankyo, Inc.Director, Omnichannel - Global Oncology Medical AffairsBasking Ridge, NJ$189,600–$284,400 / yearFull timeDemonstrated experience in content management strategy including digitalizing and modularizing medical content; Proven leadership skills in a cross-functional global team environment; Experience in managing cross-functional teams, collaborating with diverse stakeholders and with the ability to influence without authority; Strong knowledge of industry best practices; Strong understanding of regulatory requirements and compliance considerations in the pharmaceutical industry; Excellent leadership and communication skills, with the ability to partner and work with teams across regions and functions required. Cross-team Collaboration: Work with a cross-functional medical affairs team including Franchise and GMAT leads, Region (Medical, Omnichannel, and Analytics) leads, Affiliate Medical Directors, Content Team, Scientific Engagement Team, Analytics and Data Teams to enable medical engagement strategy (i.e. medical journeys with associated outcomes) and enable capability pull-through.
Director, Global Oncology Medical Affairs, Evidence Generation Daiichi Sankyo, Inc.Director, Global Oncology Medical Affairs, Evidence GenerationBasking Ridge, NJ$201,840–$302,760 / yearFull timeAs a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs Team for Alliance compounds) and as a subject matter expert (SME), in alignment with the GMAT Lead, develop an Integrated Evidence Plan (IEP), which includes an evidence gap assessment, gap prioritization and strategic delivery plan. The Director, Global Oncology Medical Affairs, Evidence Generation role is responsible for co-leading a cross-functional Evidence Generation Team and developing an Integrated Evidence Plan (IEP) for the assigned compound.
Director, Global Regulatory Affairs (GRL) Daiichi Sankyo, Inc.Director, Global Regulatory Affairs (GRL)Basking Ridge, NJ$193,040–$289,560 / yearFull timeThe GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements.
Director, Regulatory Affairs, Companion Diagnostics Daiichi Sankyo, Inc.Director, Regulatory Affairs, Companion DiagnosticsBasking Ridge, NJ$184,240–$276,360 / yearFull timeCDx RA Strategy: Represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically: Use of CTA/CDx within clinical trials. Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.
Director, Global Labeling Strategist Daiichi Sankyo, Inc.Director, Global Labeling StrategistBasking Ridge, NJ$193,040–$289,560 / yearFull timeServe as a role model for less experienced members of GRA labeling, Labeling Content Management: Manage the preparation, review, and approval of labeling content (including target labeling) for new product submissions, variations, and updates for marketed products, ensuring accuracy, consistency, and regulatory compliance. Cross-functional Collaboration: Serve as the regulatory labeling lead on cross-functional teams, working closely with Regulatory Affairs, Clinical, Medical Affairs, Safety, Legal, and Commercial to enable timely achievement of labeling milestones and project objectives.
NewDirector, Vaccine Portfolio Strategy & External Partnerships CSLDirector, Vaccine Portfolio Strategy & External PartnershipsSummit, NJ$222,000–$299,000 / yearStrategic thinking and commercial assessment expertise; ability to anticipate market shifts and create high-value deliverables from white space; strong pharmaceutical/vaccine commercialization knowledge, including lifecycle strategy, launch excellence, market access, pricing, business development, and strategic marketing frameworks; business case development, forecasting, market sizing, valuation, scenario planning, and investment prioritization capabilities; knowledge of AI and its application in R&D capabilities to assess potential opportunities, including evidence synthesis, target/product profile evaluation, development feasibility, assumption testing, scenario modeling, and risk identification; external-facing leadership with ability to guide commercial discussions, support negotiation strategy, and collaborate with Legal on CDA, MTA, services agreement, and related contracting processes; data-driven decision-making using clinical evidence, market research, competitive intelligence, policy, and regional insights; strong cross-functional leadership and ability to lead without authority; clear executive communication and stakeholder influence; executional excellence, prioritization, judgment, and learning agility. Partner with R&D inclusive of Research, Clinical Development and Medical affairs, Global Market Access & Pricing, Business planning, Manufacturing & Supply, Legal, and regions to evaluate strategic fit, commercial attractiveness, risk-adjusted value, implementation feasibility, and ensuring these inputs are appropriately reflected in portfolio assessments and business cases.
NewInternational Affairs Advisory Internship (Africa Focus) - Winter/Spring ''27 APCO Worldwide LLCInternational Affairs Advisory Internship (Africa Focus) - Winter/Spring ''27New York, NYOperating at a dynamic, fast‑paced, and consistently global level, the team offers interns meaningful exposure to international affairs work - providing opportunities to explore global issues, support cross‑regional projects, and gain insight into how APCO advises clients around the world. Headquartered in Washington, D.C., APCO is comprised of strategic advisers, consultants and creators, working together across borders and functions, to provide services and expertise on financial, competitive, political and societal issues.
NewInternational Affairs Internship (Portuguese or Spanish Bilingual) - Winter/Spring ''27 APCO Worldwide LLCInternational Affairs Internship (Portuguese or Spanish Bilingual) - Winter/Spring ''27New York, NYHeadquartered in Washington, D.C., APCO is comprised of strategic advisers, consultants and creators, working together across borders and functions, to provide services and expertise on financial, competitive, political and societal issues. APCO is a trusted partner to bold purpose-led leaders, lawmakers, government officials, NGOs, the media and other stakeholders in the health, energy, technology, transportation & infrastructure and food & consumer products sectors.
NewSr Manager, International Device Regulatory Affairs Biogen IncSr Manager, International Device Regulatory AffairsNY$138,000–$184,500 / yearRegular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. About This Role: As the Senior Manager of International Device Regulatory Affairs, you will lead regulatory strategies and execution for high-risk implantable medical device submissions beyond the United States, focusing on Japan, China, and Latin America.
Scientific Director Senior Medical Director Multiple Myeloma International Medical Affairs AbbVie IncScientific Director Senior Medical Director Multiple Myeloma International Medical AffairsFlorham Park, NJThe Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Scientific Director / Senior Medical Director, Multiple Myeloma (International Medical Affairs) AbbVie, IncScientific Director / Senior Medical Director, Multiple Myeloma (International Medical Affairs)Florham Park, NJThe Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Program Manager, Fellowship Affairs Council on Foreign RelationsProgram Manager, Fellowship AffairsNew York, New York$78,000–$87,000 / yearTo that end, CFR is dedicated to continuing to advance diversity, equity, and inclusion throughout its work and workplace by building a more diverse membership and staff, producing and dispensing thoughtful analysis on a broad range of foreign policy issues, and developing relevant, wide-reaching programming that also serves to expand the foreign policy talent pipeline to underrepresented populations. About CFR: The Council on Foreign Relations (CFR) is committed to fostering a foreign policy community in the United States that is more representative of American society, recognizing that diverse backgrounds and perspectives contribute to broader, more informed participation in the foreign policy debate and lead to an enhanced understanding of the world and the United States’ role therein.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Executive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonRahway, NJ$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
Senior Director - Scientific Affairs, North America & Latam PepsiCo IncSenior Director - Scientific Affairs, North America & LatamValhalla, NY$157,200–$312,000 / yearIn addition to salary, PepsiCo offers a comprehensive benefits package to support our employees and their families, subject to elections and eligibility: Medical, Dental, Vision, Disability, Health, and Dependent Care Reimbursement Accounts, Employee Assistance Program (EAP), Insurance (Accident, Group Legal, Life), Defined Contribution Retirement Plan. Partner with regional and global teams to shape and execute international scientific affairs strategies, including leading horizon scanning efforts to anticipate emerging scientific, regulatory, policy, and stakeholder issues and coordinate proactive responses.
Associate Scientific Director Medical Affairs - Gynecologic Tumors AbbVie IncAssociate Scientific Director Medical Affairs - Gynecologic TumorsFlorham Park, NJWorking under the leadership of the Senior Director, this position supports the development and execution of the therapeutic area medical strategy including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Associate Scientific Director, Medical Affairs - Gynecologic Tumors AbbVie, IncAssociate Scientific Director, Medical Affairs - Gynecologic TumorsFlorham Park, NJWorking under the leadership of the Senior Director, this position supports the development and execution of the therapeutic area medical strategy including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Public Affairs Associate Ralph Lauren CorpPublic Affairs AssociateNew York, NY$62,000–$95,935 / yearThe Company's brand names, which include Ralph Lauren, Ralph Lauren Collection, Ralph Lauren Purple Label, Polo Ralph Lauren, Double RL, Lauren Ralph Lauren, Polo Ralph Lauren Children, Chaps, among others, constitute one of the world's most widely recognized families of consumer brands. Coordinate with key business partners including but not limited to Global Corporate Communications, Sourcing, Sustainability, Global Citizenship, Legal and the Local Commercial teams to develop policy positions and align on advocacy needs across the organization.
Senior Regulatory Affairs Specialist Varian Medical Systems IncSenior Regulatory Affairs SpecialistNYRemote$117,770–$161,931 / yearIt is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". As a Senior Regulatory Affairs Specialist, you will be responsible to: Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
Head of Global Medical Affairs Praxis Precision Medicines IncHead of Global Medical AffairsNY$310,000–$360,000 / yearWork closely with members of the senior management team, to develop the overall strategic direction for Praxis; evaluate alternative strategies, identify competitive issues, capitalize on core strengths, and develop and implement operating plans to achieve objectives for profitable growth. Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with various levels of scientific and technical knowledge.