- Merck & Co. (Rahway, NJ)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates in ... clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members through… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strong technical knowledge based upon academic training and job experience.Strong oral and writing skill. Able to write regulatory documents in highly complex ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and ... while improving and protecting patient access to care. Reporting to the Associate Vice President, Human Health and Manufacturing Communications, the Executive … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: ... 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. (Bernards, 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… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …exciting and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory ... content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Associate Director , Data Management is responsible for oversight of data ... management for clinical development studies within all MTPA therapeutic areas. The Associate Director works with departmental and cross-functional teams to… more
- The Institute for Family Health (New York, NY)
- ASSOCIATE DIRECTOR WIC PROGRAM Job Details Level Management Job Location WIC Sites 2 - New York, NY Position Type Full Time Education Level 2 Year Degree Salary ... and Children (WIC) under the supervision of the WIC Director , Associate Director or the...including typing, Microsoft word, Excel, Power Point + Good writing and organizational skills + Strong interpersonal skills. Qualifications… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Sciences contributes to the development, evaluation, planning and execution of hematology clinical studies and ensures ... and deliver on clinical studies and programs. As an Associate Director , a typical day may include...Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate… 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
- Bristol Myers Squibb (Madison, NJ)
- …centralized monitoring for trials across the BMS Research & Development portfolio. The Associate Director , External Data Acquisition is a leadership role with ... directly contributes to the BMS R&D pipeline. This role reports to the Director , External Data Acquisition within GDM and is a full-time, office-based position.… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Clinical Scientist** This position drives scientific planning, strategy and execution of ... trial team. + Collaborates with the Medical Writer on clinical/scientific and regulatory documents. + Partners with Study Manager on study deliverables. +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Biostatistics is responsible for providing statistical support to ... deliverables for contracted statistical services. + Provides statistical components of regulatory submissions. + Assists the Department Head in the preparation of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Statistical Programming is responsible for building and maintaining ... programming requirements in the preparation of documents for submission to regulatory authorities, including but not limited to, Investigational Drug Applications… 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
- Merck (Rahway, NJ)
- …Quality, Supplier Development & Performance Management, Planning, Procurement, and Regulatory . Responsibilities contain technical, regulatory , and business ... develop right-sized solutions for component related projects and activities + Technical writing proficiency + Ability to travel to our Company manufacturing and… 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
