Labeling Strategy Manager/Associate Director of Labeling - Gaithersburg, MD | Biospace
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Labeling Strategy Manager/Associate Director of Labeling

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
12/10/2016
Position Type:
Full time
Job Code:
R-000724
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, United States
Macclesfield, United Kingdom
Gothenburg, Sweden
Job reference: R-000724
Posted date: Nov. 16, 2016


 

   At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Global Labeling Strategy Manager or Associate Director you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.  

   Main Duties and Responsibilities  

   The Global Labeling Strategy Manager/Associate Director provides regulatory labeling expertise to GRAPSQA and cross functional teams, under the leadership of the Global Labeling Director. In this role, you will leads or assists the development/production and maintenance of defined global labeling documents for all AstraZeneca marketed or pipeline products and supports the daily activities of the Global Labeling Director in addition to managing strategic labeling activities for assigned products.  You will also assists in the training of Global Labeling Group staff with regard to regional health authority requirements.  

   It will be your responsibility to ensure the labelling process is maintained, as well as contribute and lead to development of global labelling strategies for assigned products. This role will require you to lead, prepare and maintain core labelling documents as well as contribute strategically with internal and external teams in a multitude of ways.  

Requirements

   Essential Requirements  

 
       
  •      University Degree in Science or related discipline    
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  •      3 to 5 years pharmaceutical experience, including   regulatory experience, preferably working with labeling     
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  •      Knowledge of labeling regulations and guidances    
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  •      Excellent verbal and written communication skills    
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  •      Keen attention to detail and accuracy    
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  •      Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.    
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  •      Ability to assimilate clinical and scientific information and present it in a concise manner    
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  •      Ability to think strategically, appropriately assess risks and formulate strategies to manage risk    
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  •      Must demonstrate competencies in:  Building Relationships (works well across formal and informal networks), Negotiation Skills (good listener; able to build a consensus), Critical Information Seeking (works well across formal and informal networks), Rational Persuasion (able to distil an issue to its key components and suggest solutions), and Interpersonal Awareness (aware of how actions affect other people)    
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   Desirable Requirements  

 
       
  •      Experience in Labeling development and/or maintenance    
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  •      Knowledge of major markets Labeling regulations    
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  •      Advanced academic training is highly desirable (PharmD, PhD)    
  •  

   Next Steps -- Apply today!  

   To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.  

   AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law  

   ~bsp