Promotional Regulatory Affairs Reviewer (Assoc Dir/Sr Mgr) - 2 Positions: AstraZeneca Pharmaceuticals

You can at AstraZeneca.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. We have received many honors, including:

• Fortune World's Most Admired Companies list (2009)
• Woman Engineer Magazine's 18th Annual "Top 50 Employers" (2008)
• The Times Top 100 Graduate Employers (2007-2008)
• CEO Cancer Gold Standard Reaccreditation, CEO Roundtable on Cancer (2008 & 2009)
• 100 Best Companies for Working Mothers by Working Mother Magazine (2002 - 2008)
• 100 Best Companies to Work For in America by Fortune Magazine* (2008) *Only large pharmaceutical company included on the list
• Diversity MBA Magazine Top 50 Companies in Diversity Leadership (2008)
• Men's Fitness Top 15 Fittest Companies in America (2008)
• The Scientist Best Places to Work in Industry (2008)
• Fit-Friendly Company Award, American Heart Association (2007)
• Top Employer, Science Magazine (2002 - 2007)

Promotional Regulatory Affairs Reviewer (Assoc Dir/Sr Mgr) - 2 Positions

Job Summary

Responsibilities

Promotional regulatory reviewer for one or more AstraZeneca brands. Responsible for review and approval of promotional material and marketing activities for all segments (HCP, Consumer, Managed Markets), media (print, broadcast, electronic), sales training, faculty training, study recruitment advertisement and Corporate Affairs communications. Lead or work on PRA initiatives and Centers of Expertise.

Major Responsibilities:
· Responsible for review, approval, and promotional regulatory compliance of all proactively disseminated marketing material and information used for commercialization purposes
· Develop and implement US promotional regulatory strategies for assigned brand team(s)
· Provide PRA support to the Emerging Brands, including providing input into target product claims and profiles
· Responsible for the content of promotional regulatory submissions
· Take the lead to resolve promotional-related issues for assigned brand team(s)
· Identifies material needing medical and/or legal review; facilitates the review and approval of the material through serial, parallel, or team review
· Apply regulatory, therapeutic area and clinical knowledge to brand team marketing objectives and initiatives; propose creative solutions to challenging promotional campaigns that meet marketing objectives while minimizing regulatory risk
· Lead and facilitate cross-functional (Legal, Clinical, PRA, Medical Resources, Commercial) review team; facilitate resolution of disagreements
· Liaison with the FDA/DDMAC under the direction of Primary Review Director or PRA Skills Leader.

Qualifications

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

We want you to build a balanced life at AstraZeneca. Your career is just one part of that. We offer competitive salaries, rewards and recognitions for your invaluable time and efforts. We also bring you all the things you need to for your life outside of your work:

• generous health and welfare benefits
• flexible scheduling
• child care programs
• learning and development opportunities
• fitness centers
• and other personal conveniences

At AstraZeneca, we put people first. Whether it's the patients we help or the employees who make everything we do possible.

AstraZeneca is an equal opportunity employer.