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Submission Writer New Jersey
8/28/2015 7:51 AM

Responsibilities: Production of high quality clinical documentation: Clinical Study Report, Risk Management Plan, CTD submission documents (summary of clinical efficacy and safety, and efficacy and safety updates). 2. Act as a member of submission teams. 3. Can act as submission coordinator to ensure provision of adequate medical writing resources for dossier preparation and co-ordina  ...View Job
Study Start-up Specialist CDA New Jersey
8/27/2015 6:44 AM

The position will be extremely familiar with Third Party Studies (TPS), Informed Consent Forms (ICF), clinical trial privacy regulations, confidentiality agreements, the study start up process, individual patient INDs, and required trial master file documentation. The position will work under the direction of the Head of the Third Party Study Start-Up, Compassionate Use and ICF Groups. 1. Hands  ...View Job
Study Start-up Specialist New Jersey
8/27/2015 6:44 AM

The position will be extremely familiar with Third Party Studies (TPS), Informed Consent Forms (ICF), clinical trial privacy regulations, the study start-up process, individual patient INDs, and required trial master file documentation. The position will work under the direction of the Head of the Third Party Study Start-Up, Compassionate Use and ICF Groups. 1. Hands on specialist to process, c  ...View Job
Senior Global Program Regulatory Manager (Associate Director) New Jersey
8/25/2015 6:45 AM

The Senior GPRM works independently under limited supervision to provide strategic and operational regulatory direction and may support the GPRD for programs through development, registration and approval/post approval. The Senior GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the GPRD. In certain cases, the GPRM may be the GPT re  ...View Job
Medical Director/Senior Medical Director (Oncology) New Jersey
8/24/2015 6:59 AM

Novartis Pharmaceuticals is looking for an MD/DO, Hematologist/Oncologist (Sr. Director/Exec. Director) with Clinical Research interest to join our successful and growing US CDMA organization. Novartis Oncology is a leader in discovering, developing and marketing innovative drugs for patients with cancer. He/she will provide strategic medical and scientific leadership in the CML and GIST p  ...View Job
Sr Data Manager New Jersey
8/24/2015 6:59 AM

Responsible and accountable for managing all Data Management deliverables with respect to cost, quality and timelines for all assigned programs, indications or trials managed within Oncology Data Management. Ensure consistently high quality data available for analysis and reporting. • Provides DM leadership across several trials within a program , or an indication within a program or a sm  ...View Job
Global Correlative Science Leader New Jersey
8/24/2015 6:59 AM

Supports the development of oncology compounds by supporting the implementation of scientifically-driven clinical development plans, including correlative scientific compo-nents in all pivotal studies. Acts as pathway subject matter expert within the clinical de-velopment team. 1. Ensures timely execution of patient selection, stratification, pharmacodynamic and cor-relative studies for clinical t  ...View Job
Senior Manager, DRA Oncology Process Improvement and Excellence (PIE) New Jersey
8/21/2015 7:07 AM

Job Purpose: Supporting the Global Head PIE with the global and local (Basel and US, as per location of the position) development and implementation of: • enhanced regulatory quality processes and procedures, • enhanced line function excellence and standards Responsibilities: 1. Drive the management and implementation of the DRA Quality Plan within DRA: a) Devise   ...View Job
Associate Director, Global MSL & Medical Information New Jersey
8/20/2015 7:12 AM

Responsible for Global medical information and MSL activities for defined oncology product(s) and/or related disease states including global medical information & MSL strategy, planning and execution. Responsibilities will also include the development and implementation of strategy to establish medical information excellence worldwide. Major Accountabilities: Develop Global Medical Infor  ...View Job
Sr Biostatistician New Jersey
8/20/2015 7:12 AM

Responsible for all statistical tasks on the assigned clinical trials: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses, and additional analysis to support publications. Provide statistical consultation to clinical team and support decision making process by providing adequate information. Track clinical trial activities and milestones. Ensure time  ...View Job
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