Medical Communication Scientist - Gaithersburg, MD | Biospace
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Medical Communication Scientist

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
12/9/2016
Position Type:
Full time
Job Code:
R-000713
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, United States
Cambridge, United States
Job reference: R-000713
Posted date: Oct. 26, 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 Medical Communications Scientistyou’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  

 

   You will provide expert communications leadership to the drug projects of a world-leading biopharmaceutical company. You will join us at two of our worldwide research bases: Cambridge in the UK, where we are investing in a new, state-of the-art Global R&D Centre; and Gaithersburg in the US. In either location, you'll thrive in a culture of scientific excellence and collaboration.  

 

   You will communicate evidenced-based product knowledge in a way that is credible, consistent and compliant; lead the authoring of clinical-regulatory documents for MAA/NDA submission packages. You will provide expert communications leadership to drug projects and drive strategic medical writing, advocating communications excellence in your team as you lead the efficient planning and authoring of clinical submissions. You will provide strong partnership with vendor medical writers to ensure delivery to time, cost and quality. You will move on from writing study-level documents to authoring more complex documents and submissions, taking on more strategic responsibilities and leading global authoring teams.  

 

   Lead development of the submission communication strategy for a new product, liaising with senior project staff and prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported. Lead the authoring of clinical documents for the NDA and MAA and author the most complex and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees). Lead a team of medical writers (internal and external) to deliver, ensure alignment of clinical submission documents with the proposed prescribing information and represent medical writing on the high-level, cross-functional submission team. You will collaborate with the medical writing team leader to develop resourcing strategies, develop and implement new best practices in communication and submission development and train and develop less experienced Medical Communication Scientists.  

Requirements

   Essential Requirements  

 
       
  •      Bachelor's degree in the life sciences    
  •    
  •      Strong experience in regulatory medical writing    
  •    
  •      Minimum of two years' experience within the pharmaceutical/medical industry/CRO,    
  •    
  •      Broad working knowledge of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical-regulatory documents/submissions.    
  •    
  •      Ability to work well with vendors    
  •    
  •      Comprehensive knowledge of current regulatory guidelines relating to regulatory communications.    
  •    
  •      Excellent communication skills.    
  •    
  •      Willingness to undertake domestic and international travel as required by the project.    
  •  

   Desirable Requirements  

 
       
  •      MSc or PhD    
  •  
 
       
  •      Consistent display of ability in project management, thinking (conceptual, analytical and integrative), influencing and team working. Flexibility in adapting to changing circumstances or new information.    
  •  

   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