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 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
|
| Astellas Pharma, Inc. |
Deerfield |
IL |
11/19/2009
|
| Associate Medical Director/Medical Director, Medical Affairs, |
| M.D. degree, Board Certified or Board Eligible in Designated Specialty (preferred) with subject matter expertise in dermatology or ImmunologyThree years clinical or clinical research experience preferredOne year experience in the pharmaceutical industry preferredExcellent communication and presentation skills, strong interpersonal skills.Strong clinical research/medical affairs background, and excellent problem solving abilities.Demonstrate abilities to work effectively in a team environment.Ability to interpret and evaluate clinical data. Leadership skills and ability to effectively manage projects and timelines. Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development. Knowledge of FDA, other regulatory agency and professional requirements, regulations and guidancesAble to work independently on all aspects of assigned projectsExcellent organizational skills |
| Johnson & Johnson Family of Companies |
|
CA |
11/19/2009
|
| Associate Director, Regulatory Affairs (Santa Barbara, CA) |
| A minimum of a BA/BS degree and RAC certification are required; an advanced degree is strongly preferred. A minimum of 5 years experience in a senior Regulatory Affairs and/or CMC role within Biotech and/or Pharmaceuticals is required. Regulatory Project Management experience is required. Experience in biologics is required. Experience in preparing BLAs in eCDT format is required. Strong knowledge of regulatory requirements (21 CFR Parts 312, 600, 601, 610 and 820) and CMC experience are required. Experience selecting and managing outside vendors is required. Experience processing electronic submissions is required. Global experience is preferred. Travel approximately 25%, but can go up to 80% during peak times with regular travel to manufacturing facility in Madison, WI. PMP certification is preferred. |
| 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 |
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| Millennium Pharmaceuticals |
Cambridge |
MA |
11/19/2009
|
| Sr Mgr, Regulatory Affairs |
|
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