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| Novartis Oncology |
na |
NJ |
11/20/2009
|
| Senior Roles-Regulatory Affairs, R&D |
| 10+ years extensive Regulatory Affairs experience. An academic background in biological/medical sciences (preferably MD or PhD), strong diplomatic skills for dealing with regulatory agencies ability to realize a vision by inspiring and motivating others, ability to thrive and grow in a fast-paced, intellectually challenging environment, are additional important requirements. Candidate should be fluent in English. |
 Millennium Pharmaceuticals |
Cambridge |
MA |
11/19/2009
|
| Dir, Regulatory Affairs |
|
| Johnson & Johnson Family of Companies |
South San Francisco |
CA |
11/19/2009
|
| Senior Clinical Budget Analyst - Janssen AI, LLC |
| A Bachelor's Degree is required. Working knowledge of the clinical development process and 2+ years of experience in clinical budget development and management are required. Must possess an understanding of clinical trials, regulatory affairs, quality assurance, clinical trial materials, budgeting and routine contracts. Previous experience with industry benchmarking database(s) is strongly preferred. Excellent communication skills (both oral and written) are required. The ability to work effectively in cross-functional teams is required. Strong and proven negotiation and problem resolution skills are also required. Strong business acumen and an innovative spirit are required. Strong inter-personal and collaboration skills are required. Must possess the ability to accomplish substantial tasks with minimal supervision. Experience in assisting and drafting of legal contracts and familiarity of clinical budget development and negotiation is required. |
| Millennium Pharmaceuticals |
Cambridge |
MA |
11/19/2009
|
| Dir, Regulatory Affairs |
|
| Millennium Pharmaceuticals |
Cambridge |
MA |
11/19/2009
|
| MGR II, REGULATORY AFFAIRS |
|
| Millennium Pharmaceuticals |
Cambridge |
MA |
11/19/2009
|
| Sr Mgr, Regulatory Affairs |
|
| Vertex Pharmaceuticals |
Cambridge |
MA |
11/19/2009
|
| Associate Director, Regulatory Affairs |
| M.S. (or equivalent degree) and 6+ years relevant work experience.
B.S. (or equivalent degree) and 8+ years of relevant work experience.
PhD preferred.
Vertex Pharmaceuticals |
| Novartis Oncology |
na |
NJ |
11/20/2009
|
| Medical Dir/Senior Medical Director US Medical NSO (Neuroscience) |
| A MD degree with 3-7 years? clinical trial experience and Board Certification/Eligibility in Neuroscience is required; direct pharmaceutical industry experience will be a plus.
? Experience in managing clinical trial conduct for neurological 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 neuroscience therapeutics and of bridging proactive relationships among product development, clinical development and marketing teams.
? Strategic business perspective required to bring launched and pre-launch compounds forward as commercially viable drugs.
? 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.
? Experience leading large projects/organizations.
? Excellent oral and written communication skills. |
| AstraZeneca Pharmaceuticals |
Delaware |
DE |
11/19/2009
|
| Primary Reviewer Director; PRA |
Skills and Competencies
? Advanced degree in pharmacy, pharmacology or other life sciences or equivalent experience in the therapeutic area
? 10+ years experience in regulatory affairs with at least 5 years in review and approval of product promotional material or 15+years relevant pharmaceutical experience
? Comprehensive understanding of relevant promotional regulations and guidances including those relevant to labeling, product promotion and scientific exchange of information
? Working understanding of drug development process
? Significant experience (5 years) interacting with FDA/DDMAC and an understanding of drug development process
? Excellent verbal, written and communication skills with an ability to write and articulate regulatory/scientific arguments in a persuasive manner
? Experience in managing and directing staff
? Demonstrated experience in project management, ability to lead project teams, and manage projects to completion
Preferred
? 1-2 years experience interacting with FDA/OND
? Drug Development experience 1-3 years
? 4-5 years experience in managing and directing staff
? Experience in and understanding of respiratory products
 |
| AstraZeneca Pharmaceuticals |
Delaware |
DE |
11/19/2009
|
| Promotional Regulatory Affairs Reviewer (Assoc Dir/Sr Mgr) - 2 Positions |
| Minimum:
? Degree in pharmacy, pharmacology or other life sciences or equivalent experience
? 5+ years experience in regulatory affairs with at least 2 years in review and approval of product promotional material or 10+ years relevant pharmaceutical experience
? Working understanding of relevant promotional regulations and guidances including labeling, product promotion and scientific exchange of information
? Experience interacting with FDA/DDMAC (1-3 years)
? Demonstrated ability to review product promotional material, identify false and misleading information, and propose alternate solutions to mitigate risks
? Ability to lead and facilitate team meetings and managing/resolving conflict
? Experience working in a team-based environment
? Excellent verbal, written and communication skills and ability to write and articulate persuasive scientific/regulatory arguments
? Experience in project management
? Demonstrated proficiency in the following competencies: ethics, standards, attention to detail
Preferred:
? Direct experience interacting with FDA (1-2 years; Review Division)
? Understanding of drug development process
? Pharmaceutical marketing or commercial experience
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