- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Job Summary:** The Associate Director of Regulatory Writing is a key role responsible for ... strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working… more
- Bristol Myers Squibb (Madison, NJ)
- …external resources; ensure appropriate quality controls in place for compliant submissions + Writing regulatory documents (eg new INDs, briefing book content, BT ... careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Policy Advocacy** The Associate Director , Policy Advocacy serves as the senior expert ... in advancing policy change in support of the company's business objectives. The Associate Director will proactively research and stay abreast of new strategies… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Policy Strategy and Capabilities** The Associate Director , Policy Strategy and ... reporting to the Executive Director , Policy Development & Strategy. The Associate Director will develop and maintain the strategic planning digital platform,… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Summary** The Market Access/HEOR GBDS Associate Director provide statistical support to Market Access/HEOR ... to successfully enable market access and price negotiations. With appropriate experience, the Associate Director can take a lead role in the statistical aspects… more
- Educational Alliance, Inc. (New York, NY)
- …arts and culture, and civic engagement. The Role: Under the direction of the Director of Compliance, the Associate Director of Compliance is responsible ... of the Center for Recovery Wellness (CRW) residential and outpatient components. The Associate Director of Compliance will oversee the adherence to all relevant… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. **Summary** The Associate Director will be responsible for developing and implementing ... global function on study and project teams + Produces independent writing for publications & regulatory documents + Serves as a specialist in PK-PD and Pop… more
- IQVIA (Parsippany, NJ)
- **Job Overview:** This position is an Associate QA Director in the Customer Strategy team who will serve as the strategic quality engagement lead for one or more ... audit plan. * Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …knowledge based upon academic training and job experience. + Strong oral and writing skill. Able to write regulatory documents in highly complex technical ... working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Bristol Myers Squibb (Madison, NJ)
- …+ Protocol and ICF development process with minimal guidance; including writing , reviewing, adjudication/resolution of cross functional comments and ensuring high ... clinical quality (collaboration with Medical Writing ) + Site-facing activities such as training and serving...of clinical study reports (CSRs) and clinical portions of Regulatory Documents (eg, IB, DSUR, regulatory responses)… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to management and development teams. + On an as-needed basis, interacts with regulatory agencies worldwide on issues of nonclinical safety evaluation. + Writes and ... globally. + Participates in discussions with internal development teams and/or regulatory agencies to address safety findings and provide safety assessments. +… more
- MetLife (Whippany, NJ)
- …markets; the derivative instruments used to manage risk; and the accounting and regulatory environment of both insurance companies and asset managers. They will work ... experience a plus * Experience developing hedging solutions a plus * Experience writing about derivative markets and strategy a plus * Masters of Business… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of sourcing strategies for a specific set of R&D categories (CRO, Medical Writing , BDM, etc..). Builds strategic plans for specific categories under the direction of ... - Demonstrates strong knowledge of the industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing strategy… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. + CRO / Vendor ... Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. + CRO / Vendor ... Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health… more
- Merck (Rahway, NJ)
- …, Operations, Non-clinical, Clinical, and other functional areas + Experience with regulatory submissions including writing / review of regulatory ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Research Foundation CUNY (New York, NY)
- …Programs (GSP) Office of the CUNY School of Medicine and Reporting to the Associate Dean for Research, the GSP Director manages and supports full-time staff ... Job Title: Director of Grants & Sponsored Programs PVN ID:...and works closely with the Associate Dean for Clinical Administration, Finance, & Strategy to… more
- Compass Group, North America (New York, NY)
- Crothall Healthcare Salary: $115K to $125K Other Forms of Compensation: 9% Yearly Director Bonus Potential Crothall Healthcare is a Compass One Company that provides ... more at www.Crothall.com. Job Summary Working as a Healthcare Facilities Management Director , you lead the overall management of the Plant Operations & Maintenance… more
- Publicis Groupe (New York, NY)
- …and career development + Provide estimates for SOW development + Work with the Director , Regulatory Review in the development of departmental SOPs + Oversee work ... www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Sr Manager, Regulatory Review is responsible for managing a large team… more
- Publicis Groupe (New York, NY)
- …and career development + Provide estimates for SOW development + Work with the Director , Regulatory Review in the development of departmental SOPs + Oversee work ... and experience of a global leader. **Job Description** The Senior Manager, Regulatory Promotional Operations is responsible for managing a large team of Associates,… more