- Merck & Co. (Rahway, NJ)
- …the organization.Interface with Corporate, Division, plant and external community organizations/ agencies regarding EHS&S issues and strategy. Serve as single EHS&S ... relationships with stakeholders.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders; escalates issues rapidly to… more
- Merck & Co. (Durham, NC)
- …with strategic direction defined by the global business model and regulatory agencies .- The role will require working with Operations, Technology, Supply Chain, and ... Experience as Subject Matter Expert (SME) in presenting to regulatory agencies . Quality Auditing experience Working Relationships Reports to Director, Quality… more
- Merck & Co. (Durham, NC)
- …with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,).Equipment ValidationRoot cause analysis methodologyKnowledge ... Compendia testing specific to the pharmaceutical industryExperience in regulatory agency audits and/or regulatory filingsExperience in technical writing, including… more
- Merck & Co. (North Wales, PA)
- …evidence needs of clinicians, health systems, payers, policymakers, and HTA/reimbursement agencies .The job duties include the following: Leads and/or contributes to ... workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex,...hired by our company as a result of an agency referral where no pre-existing agreement is in place.… more
- Merck & Co. (Rahway, NJ)
- …supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).-Current Employees apply HERE Current Contingent ... workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex,...hired by our company as a result of an agency referral where no pre-existing agreement is in place.… more
- Merck & Co. (Rahway, NJ)
- …teamsKnowledge of regulatory requirements and experience with relevant regulatory agencies (FDA, EMA, PDMA, etc.)Current Employees apply HERE Current Contingent ... workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex,...hired by our company as a result of an agency referral where no pre-existing agreement is in place.… more
- Merck & Co. (South San Francisco, CA)
- …generation, analysis, and reporting to project teams, governance bodies, and regulatory agencies , and manage key timelines and milestonesLead and develop a group of ... workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex,...hired by our company as a result of an agency referral where no pre-existing agreement is in place.… more
- Merck & Co. (South San Francisco, CA)
- …analysis, and reporting to project teams, governance bodies, and regulatory agencies .Drive scientific innovation and champion new enabling technologies and methods ... workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex,...hired by our company as a result of an agency referral where no pre-existing agreement is in place.… more
- Genmab (Plainsboro, NJ)
- …strategies and advice for products and programs. Interact with the global health agencies and US FDA for assigned projects. The US/GRL will lead and/or participate ... Build strong relationships with key external stakeholders including regulatory agencies , professional societies, and key opinion leaders Participate in review… more
- Merck & Co. (Millsboro, DE)
- …and other information as needed for annual reports to Federal regulatory agencies . Leadership for internal and external regulatory inspections (USDA, DEA, DNREC, ... workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex,...hired by our company as a result of an agency referral where no pre-existing agreement is in place.… more
- Insmed Incorporated (Dallas, TX)
- …Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, ... or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will... if a formal agreement between Insmed and the agency has been established. The Human Resources department is… more
- Insmed Incorporated (San Diego, CA)
- …Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, ... or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will... if a formal agreement between Insmed and the agency has been established. The Human Resources department is… more
- Merck & Co. (Rahway, NJ)
- …in IND, NDA and other submissions to global regulatory agencies .Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, ... workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex,...hired by our company as a result of an agency referral where no pre-existing agreement is in place.… more
- Insmed Incorporated (San Diego, CA)
- …Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, ... or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will... if a formal agreement between Insmed and the agency has been established. The Human Resources department is… more
- Insmed Incorporated (Chicago, IL)
- …Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, ... or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will... if a formal agreement between Insmed and the agency has been established. The Human Resources department is… more
- Insmed Incorporated (San Diego, CA)
- …Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, ... or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will... if a formal agreement between Insmed and the agency has been established. The Human Resources department is… more
- Insmed Incorporated (San Diego, CA)
- …equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual ... opportunity, and reasonable accommodation for individuals with disabilities in employment , its services, programs, and activities. To request reasonable… more
- Merck & Co. (Rahway, NJ)
- …current product portfolio and new product launches. Manage public relations agency and related program budgets to implement best-in-class HPV communications plans. ... partnership success with colleagues in marketing, policy, and investor relations. Agency experience may also be relevant.Current Employees apply HERE Current… more
- Merck & Co. (Rahway, NJ)
- …product guidelines and policy regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings. - ... for submission and approval of complex INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, and replies to health authority… more
- Merck & Co. (Rahway, NJ)
- …as be the primary point of contact for collaboration with contractors and agency partners. This individual will also serve as a company spokesperson and represent ... workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex,...hired by our company as a result of an agency referral where no pre-existing agreement is in place.… more
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