|
Search Jobs
|
Page 1 |
2
| >>
|
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Manager QA Computer System Validation |
Education/Experience Qualified candidates had a minimum of 5 years experience with a world class pharmaceutical quality organization; first hand knowledge of computer system validation related to pharmaceutical manufacturing, clinical development, QC/QA, and regulatory affairs; and experience in auditing computer system validation/software development life cycle (SDLC) processes. Direct dealings with FDA and other regulatory agencies is a plus. Strong appreciation of the impact of regulatory bodies on pharmaceutical operations.International experience is a plus; but at minimum, experiences working with diverse cultures and employees. Quality processes and regulations (e.g., cGMP, GCP, and GLP regulations) Computer system validation/SDLC processes; auditing skills; risk management skills Sets high performance expectations and holds others responsible for the expected results. Acts with a sense of urgency; is able to work with a wide variety of people and takes actions that are best for Daiichi Sankyo versus any individual operating group. Enhances performance by doing things that are unique and takes well-calculated risks in decision making. Adapts easily to new circumstances and is flexible in a work environment that makes frequent changes in its demands. Coaches both internal and external employees on ways to improve performance. Encourages the free exchange of information and opinion even when they may be negative or unpopular. Asks for support from others when necessary and genuinely respects their point of view. Demonstrates respect for and capitalizes on cultural diversity and seeks out perspectives when developing strategies, both international and domestic. Has a natural “can-do” attitude and approach to issues and instills this attitude in others. Takes ownership of processes and results regardless of their outcome. Realizes the contribution that others are making and gives credit to them when appropriate. Creates an environment that enhances trust. Demonstrates principled leadership and ethics and expects the same from others. Must be willing to commute 20% of time. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Director Risk Management |
Education/Experience MD (or PhD in a relevant scientific discipline), Board certification or eligibility. 3-5 years experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Senior Director 7- 10 years. Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist. Ability to review and analyze data and communicate complex information and analyses to a variety of scientific and non-scientific audiences. Proven ability to think creatively and to develop strategic plans that demonstrate sound judgment. Experience working cross-culturally in a global pharmaceutical environment. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Project Data Manager |
Education/Experience Qualified canddiates must have a Master's degree; Bachelors degree or registered nurse in life sciences; 4 to 6 years (MS) pharmaceutical/data management; 6 to 8 years (BS/RN) pharmaceutical/data management. Project management experience is preferred. Demonstrated knowledge of clinical data flow and research design; clinical database administration and system validation experience; demonstrated competence with GCP/regional regulatory guidelines, SOPs (including WPs), medical terminology, standard coding dictionaries, and demonstrated proficiency in applying them to all relevant therapeutic areas and CRO management experience, including a thorough knowledge of CRO audits are critical skills in this role. EDC and SDTM experience is preferred. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Manager, Medical Writing |
Education/Experience Qualified candidates must have a PharmD, PhD in biological sciences. MD is strongly preferred. Otherwise exceptional candidates with a MS or BS/BA may be considered. Minimum requirement of 3 years experience with PharmD or PhD, 5 years with Masters’ Degree or 7 years with a BA/BS. Experience in writing regulatory documents (protocols, Investigator Brochures [IBs], Clinical Study Reports (CSRs), clinical sections of the CTD [2.5, 2.7.3, 2.7.4], integrated summaries of efficacy and safety [ISE and ISS], briefing books, and regulatory responses) in the pharmaceutical or CRO environment required; ability to interpret and organize scientific data; and general understanding of clinical research, biostatistics, electronic publishing, and relevant industry guidelines (GCP, eCTD, and ICH). Marketing submission experience (NDAs or MAAs) preferred but not required. Daiichi Sankyo develops or has developed drugs in the following therapeutic areas: cardiovascular diseases, metabolic diseases, inflammation and immunology, infectious diseases, and oncology. Relevant therapeutic area experience preferred. Ability to quickly get up to speed on a therapeutic area, project, or indication with little to no coaching, work concurrently on several complex projects, meet aggressive deadlines, and adjust priorities rapidly as the situation demands. Strong interpersonal and communication skills (both verbal and written) are also required as the individual must be able to work in a team environment and coordinate with the team to move documents forward to completion. Must be a self-motivated person who can work with limited guidance/supervision. Excellent writing skills with a clear concise style and excellent grammar, punctuation, and spelling; proficiency in a Microsoft Windows environment; and strong MS Word skills and ability to work with templates. Excellent attention to details, especially as related to accuracy of numbers/statements and consistency within and across documents. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Sr. Director, Clinical Development, Oncology |
Education/Experience Qualified candidates must have a MD and a minimum 5 years of pharmaceutical development experience and at least 3 years of hands-on experience managing a major, multi-country, clinical program. Must be an Oncologist. Knowledge of pharmaceutical business, worldwide drug development and regulatory process. Expertise in complex clinical trial design (i.e. factorial design, etc.) and complex implementation (i.e. including Steering Committees, Safety Monitoring Boards, etc.) as well as the interpretation of scientific data. Independent thinking, creativity and innovation. Ability to deliver high quality products. Strong interpersonal skills and ability to interface effectively with multinational development teams in a multicultural working environment. Excellent communication, presentation and negotiation skills with emphasis on building consensus. Ability to effectively manage interactions with academic thought leaders ensuring optimal cooperation for achieving program and department goals. Ability to anticipate and facilitate issue resolution in a multicultural working and business environment. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Director, Clinical Development |
Education/Experience Qualified candidates must have a MD with formal training in Internal Medicine or therapeutic area related specialty. PhD or Pharm D degree candidates with extensive drug development experience are eligible and will work under the supervision of a MD Director or Senior Director. For MD, a minimum 2 years of hands-on experience with a multi-country, clinical program. For PhD or Pharm. D, a minimum of 6 years of drug development experience and at least 4 years of hands-on experience in clinical development. Knowledge of pharmaceutical business, worldwide drug development and regulatory process. Expertise in complex clinical trial design (i.e. factorial design, etc.) and complex implementation (i.e. including Steering Committees, Safety Monitoring Boards, etc.) as well as the interpretation of scientific data. Independent thinking, creativity and innovation. Ability to deliver high quality products. Strong interpersonal skills and ability to interface effectively with multinational development teams in a multicultural working environment. Excellent communication, presentation and negotiation skills with emphasis on building consensus. Ability to effectively manage interactions with academic thought leaders ensuring optimal cooperation for achieving program and department goals. Ability to anticipate and facilitate issue resolution in a multicultural working and business environment. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Director, Modeling and Simulation |
Education/Experience Qualified candidates must have a Ph.D. in Pharmaceutical science or equivalent. Minimum requirement 8 years clinical pharmacology and pharmacokinetics experience, including implementation of state of art modeling and simulation to support compound development. Expertise in M&S in support of cardiovascular, oncology and diabetics preferred. In-depth knowledge of current regulatory requirements (FDA, GCP and ICH). Ability to work independently and to effectively prioritize, proactively identify and resolve problems and work in a team environment. Must possess excellent communication and interpersonal skills, as well as effective collaboration and negotiation techniques. Highly proficient in standard computer software (Word, Excel and Power Point) and helpful to have proficiency in specialized software for pharmacokinetic data analysis. Demonstrated experience in population pharmacokinetic-pharmacodynamic modeling required using NONMEM. Experience in clinical trials simulation desirable. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Director, Oncology Clinical Supply Operations |
Education/Experience Qualified candidates must have a PhD in Pharmaceutical Science or related field; minimum 10 years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development; and excellent knowledge of Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international). Strong knowledge of clinical supply planning, manufacturing, packaging, and labeling and a working knowledge in supporting oncology clinical studies is preferred. Strong knowledge of cGMPs and GCPs for drug products; knowledge of import/export regulations; and excellent communication, negotiating, and computer skills are critical in this role. Must be willing to travel 20% of time. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Associate Director Clinical Pharmacology |
Education/Experience Qualified candidates must have a M.D. with post graduate training in clinical pharmacology or Ph.D. in Pharmaceutics or PharmD with clinical post graduate training. Minimum requirement 0-5 years clinical pharmacology and pharmacokinetics experience, including development of clinical pharmacology programs for new chemical entities and directing clinical pharmacology studies. Knowledge of pharmacokinetic and pharmacodynamic principles; clinical pharmacology, specifically a strong background in ADME principles, model based drug development paradigm, pharmacometric methods, bioanalysis principles and statistical methods; and familiarity with the preparation of regulatory submissions to various Regulatory Authorities (FDA and EMEA) are critical skills in this role. Must be willing to travel 10% of the time. |
| Daiichi Sankyo, Inc. |
Edison |
NJ |
7/30/2010
|
| Director, Global Project Management |
Education/Experience Qualified candidates must have a PhD degree preferred or other advanced degree (i.e., MS or MBA) with additional relevant experience. Minimum of 10 years experience in an R&D function within a biotech or pharmaceutical company with 5 years of pharmaceutical research and development project management experience, and an understanding of drug commercialization and marketing. Demonstrated experience motivating and leading project teams to completing all activities associated with managing product candidates through all stages of development and registration including submission of at least one major NDA/MAA or major supplemental regulatory submission. This includes coordinating integrated drug development plans, project team meeting minutes, and project schedules. Strong communication, negotiation, and computer skills. Working knowledge of Word, Excel, PowerPoint, and Project Management software applications. PMI or similar certification is a plus. Must be willing to travel 25% of the time. |
|
Page 1 |
2
| >>
|
|
