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Job Title City State Posted on
  Novartis Oncology na NJ 7/31/2010
Manager, BDL (Business Alliance)
Education: B.A. or B.S. in Chemistry, Pharmacy, or Life Sciences Experience: ? 5-7 years of Pharmaceutical industry experience (preferably in the generic sector) ? Experience should encompass more than one functional area (e.g. product development, regulatory affairs, product management, marketing, business development, finance, etc). ? Understand the basics of pharmaceutical forecasting and competitive dynamics in the pharmaceutical industry ? Understand the basics of financial analysis and product P&L modeling ? Negotiate commitments and timelines from internal and external parties ? Excellent written and oral communication skills ? Working proficiency in MS Office software tools ? MBA and experience in business development activities is preferred
  Novartis Oncology na MA 7/31/2010
Director Regulatory Affairs
Advanced degree in life-sciences, engineering or public health. 1. Greater than 7 years work related profession experience in diagnostic regulatory affairs 2. 3+ years experience in drug/diagnostic regulatory affairs. 3. 5+ years multi/cross functional leadership experience in clinical development, preferably in molecular diagnostics 4. Knowledge of drug development and regulation affairs requirements 5. Familiar with regulatory issues and challenges associated with Drug/Diagnostic co-development and companion diagnostics. 6. Have a track record in successful FDA and ROW premarket submissions and registrations 7. Solid understanding of molecular technologies and the impact on outcomes and diagnostic results 8. Leadership capabilities working across varied cultures, expertise and backgrounds 9. Excellent negotiation skills with regulatory staff on various levels of hierarchy 10. Outstanding interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
  Novartis Oncology na GA 7/31/2010
Director of Medical Affairs and Consultation- North America
OD or MD degree required Residency Trained (optional) Experience Requirements: 8 - 10 years clinical practice or industry experience. Regulatory experience required. Basic understanding of Marketing concepts. Clinical study experience(preferred). As a CIBA VISION associate, you are expected to know, understand, and comply with all applicable safety and health standards and rules. CIBA VISION is an equal opportunity employer M/F/D/V.
  Novartis Oncology na NJ 7/31/2010
Associate II, Regulatory Affairs
Language Skills Excellent oral and written communication skills Education and Experience Candidate must possess a Bachelor?s degree in Chemistry or related field and 3+ years experience in the pharmaceutical industry. eCTD experience is highly preferred.
  Novartis Oncology na NJ 7/31/2010
Associate IV, Regulatory Affairs
Education and Experience B.S. or Pharm.D. in pharmacy or B.S. in nursing or scientific field with 5 to 7 years of pharmaceutical experience including a minimum of 3 years experience in regulatory affairs. Proven ability to work effectively across a matrixed and widely-dispersed organization. Excellent interpersonal, communication, and influencing skills. Demonstrated negotiation skills and success in working with Health Authorities.
  Novartis Oncology na NC 7/31/2010
Manager, Regulatory Affairs
Good conflict resolution and problem solving skills. Strong interpersonal skills and matrix management skills. Demonstrated personnel management skills. Excellent written and verbal skills and the ability to communicate clearly, concisely and effectively. Will be an open, available, transparent communicator with good leadership and presentation skills and ability to influence. Will have high energy level and will adhere to high ethical standards. PHYSICAL DEMANDS: The physical demands of this position are consistent with those expected in an office/administrative environment. Typical activities may include work at a computer, copying, scanning, filing and, dependant on the position, considerable time may be spent sitting, standing or walking. Light lifting (up to 10-15 lbs) may be required from time to time, consistent wtih an office environment. QUALIFICATIONS: Demonstrated track record submitting and maintaining pre and post approval regulatory dossiers to FDA. Experience with Office of Generic Drugs and ANDAs a plus. Experience dealing with compliance issues addressed by health authorities. Expertise in the areas of cGMPs and GLPs. Minimum of a Bachelors degree in a scientific discipline with minimum 6 years of pharmaceutical regulatory experience. Physical Demands: The position requires close vision. The position requires distance vision. Work Environment: The noise level is usually moderate.
  Novartis Oncology na NJ 7/31/2010
Medical Dir/Sr Medical Director US Medical NSO (Multiple Sclerosis)
A MD degree with 3-5 years? pharmaceutical industry experience is required; Board Certification/Eligibility in Neurology and clinical/ research background in Multiple Sclerosis will be a plus. ? Experience in managing clinical trial conduct for neurological disorders and Multiple Sclerosis is essential. ? Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities. ? Medical Affairs and U.S. marketing experience, to include a well documented history in medical development of Multiple Sclerosis/ Neuroscience therapeutics and of bridging proactive relationships among product development, clinical development and marketing teams. ? A well-established network within the medical research community that will attract high-caliber professionals into the Novartis organization. ? Proven ability to build productive relationships and teams internally and externally, and the ability to develop high potential subordinates into leadership roles. ? Reputation as an open, available and transparent communicator. ? Strong leadership and organizational skills; demonstrated personnel management capabilities. ? Excellent oral and written communication skills. ? Experience leading large projects/organizations. ? Ability to travel (U.S. and European; 20-25% annually, up to 40% seasonally).
  Novartis Oncology na NJ 7/31/2010
Medical Director/Senior Medical Director, Psychiatry, US Medical
A MD or DO degree with 3-5 years of pharmaceutical industry experience is required; Board Certification/Eligibility in Psychiatry and clinical/research background in Psychiatry would be a plus. ? Experience in managing clinical trial conduct for psychiatric disorders is essential. ? Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities. ? Medical Affairs and U.S. marketing experience, to include a well documented history in medical development of Psychiatric therapeutics and of bridging proactive relationships among product development, clinical development and marketing teams. ? A well-established network within the medical research community that will attract high-caliber professionals into the Novartis organization. ? Proven ability to build productive relationships and teams internally and externally, and the ability to develop high potential subordinates into leadership roles. ? Reputation as an open, available and transparent communicator. ? Strong leadership and organizational skills; demonstrated personnel management capabilities. ? Excellent oral and written communication skills. ? Experience leading large projects/organizations. ? Ability to travel (U.S. and European; 20-25% annually.
 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.
  Novartis Oncology na NJ 7/31/2010
Associate II, Regulatory Affairs
Language Skills Good oral and written communication skills Education and Experience Candidate must possess a Bachelor?s degree and 3+ years experience in the pharmaceutical industry. IT and eCTD experience is highly preferred. Experience within a Regulatory Affairs Department is also a plus.
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