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 Labelling Strategy Manager/Associate Director
in Gaithersburg, MD
, 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
As the Labelling Strategy Manager/Associate Director you will lead the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating the wider impacts of the strategy and understanding the long-term consequences for the product and the wider AZ portfolio. You will be providing strategic labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidances.
You will also provide clarity regarding applicable labelling requirements and expectations in all complex situations to all relevant stakeholders at all levels, providing risk insight and proposing mitigations. You will leads the PLT in the preparation and maintenance of high quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling. You will justify and communicate the labelling rationale to Senior Leaders to enable effective decision making. You will lead the development of target labelling documents as appropriate.Essential Requirements
- University Degree in Science or related discipline
- 3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labeling.
- Knowledge of labeling regulations and guidances
- Excellent verbal and written communication skills
- Keen attention to detail and accuracy
- Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
- Ability to assimilate clinical and scientific information and present it in a concise manner
- Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
- Must demonstrate competencies in: Building Relationships, Negotiation Skills, Critical Information Seeking, Rational Persuasion, and Interpersonal Awareness
Next Steps - Apply today!
- Experience in Labeling development and/or maintenance
- Knowledge of major markets Labeling regulations
- Advanced academic training is highly desirable (PharmD, PhD)
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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca