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| Associate Manager NJ Open (J#28236) Shape Your Future And Ours. Schering-Plough is an innovation-driven, science-centered global health care company. Through our own biopharmaceutical research and collaborations with partners, we create therapies that help save and improve lives around the world. We apply our research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by our colleagues around the world. Associate Manager, Global Regulatory affairs Requisition Number: 22856BR Description: This is an entry level position in the Customer Channels, North America group. In this position, the Associate Manager, Customer Channel, with management oversight, is responsible for supporting the Global Regulatory Strategy Team (GRST) chair in developing regulatory strategic plan and assisting in tactical support of global regulatory submissions for all Schering-Plough pharmaceutical products. With management oversight, assists in ensuring that the content, organization and overall quality of all regulatory documentation are adequate and sufficient to meet local and/or regional regulatory requirements, commitments and agreements. May represent GRA and SPRI at departmental and professional meetings. Major Responsibilies: Under direct supervision and advice may compile required documents from source areas for submission Will assist in the review of critical documents to assure completeness Under direct supervision will prepare responses to routine regulatory requests Follows team tracking documents to insure submissions are completed on time With management input will assist the GRST chair in the preparation of the Regulatory Strategic Development Plan Will assist in compiling and reviewing for quality regulatory submission to meet Health Authority Commitments With direct supervision, may handle routine requests from the Health Authority (HA) or GRA colleagues in Country Operations May interact directly with national / regional HAs such as the FDA. With supervision, may review and sign-off or required regulatory packages prior to investigational drug shipments With direct supervision, may prepare routine IND/IMPD/CTA and/or NDA/MAA submissions Develops familiarity with regulatory standards and practices, regulations and guidances, Departmental SOPs and Corporate Policies and Procedures Supports the GRST chair for project team agenda items and assists in meeting cross-functional goals When appropriate and with prior direction, may represent GRA at Study Team or as substitute on Project Team Qualifications: - Ph.D. or equivalent with 0 years related experience or, Masters or equivalent with 1-3 years related experience including 1-3 years relevant regulatory experience or, B.A. or B. S. degree with emphasis in Science, Health Care or related fields with minimum 3-5 years related experience with 0-2 years relevant regulatory experience - Good written and verbal communication skills - Demonstrate Leader Behaviors: - Ability to work in cross-functional team environment - Demonstrate an ability to Learn and Listen - Ability to lead and coach others - Good interpersonal skills - Demonstrate an ability to negotiate and influence others effectively - Problem solving skills include an ability to critically analyze scientific issues/arguments - Good organizational skills and attention to detail with an ability to manage complex projects and timelines in a matrix team environment - Possess the desired SP global behavioral competencies identified on attached grid. Schering-Plough is an equal opportunity employer. M/F/D/V Click HERE to Apply: www.airspartner.com/jpartner/schering_plough.home?_jobPostingID=390810 | |||
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