PRAHS

2017-41876

- | United Kingdom
1 month ago
Title
Global Nominated Signatory Leader - Gaithersburg MD

Overview

Do you want to watch clinical development change, or do you want to be the one to shape it?

 

Because we’re hoping you’re here for the latter.

 

Who are we?

We Are PRA.

 

We are 13,000+ employees strong, operating in more than 85 countries. We are committed to saving lives, and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

 

Who Are You?

You are a natural leader with a passion for clinical development. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks. You can provide excellent leadership to not only your team, but also to clients. You are excited and enthusiastic.  You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

 

Still here? Good. Because if this is you, we’d really like to meet you.

 

Responsibilities

What will you be doing?

As a Medical Information Manager, you will be the primary liaison to your client, ensuring questions are answered and issues are resolved.  You will respond and manage Medical Information inquiries from Health Care Professionals for the Sponsor portfolio. 

 

  • Act as the sponsor parnter authority and leader on medical quality and standards for the allocated therapy area.  This includes promotional claims acceptability (including avoiding off-label claims);  interactions with healthcare professionals; cross border digital activities, medical ethical acceptability and other matters within the scope of the IFPMA Code of Pharmaceutical Marketing Practices.
  • Lead the sponsor partner approach and tone for medical standards within the designated therapy area.  Ensure that the importance is recognised and integrated into everyday business while avoiding unnecessary inhibitions to creativity and actively supporting innovation through deep understanding of the regulations.
  • Support for Global, Regional & Marketing company Medical colleagues through training that drives high medical standards.
  • Supervise the application of relevant Global Medical policies and SOPs within the allocated therapy area.
  • Guide Marketing Company Nominated Signatories and others worldwide on medical standards for the allocated brands and therapy area activities.
  • Work with commercial, compliance, audit and legal functions to develop and implement company policy interpretation and guidance on difficult and controversial compliance and ethics topics relevant to the therapeutic area.
  • Pro-actively and reactively work with the Marketing Company Nominated Signatories providing help and guidance on difficult approval issues relating to their allocated therapeutic
  • Support the Global Medical Standards Practice Director in knowledge sharing between Global, Regional and Marketing Company medical compliance functions, and other stakeholders, with respect to optimising brand messages and claims within the codes, regulatory and ethical constraints.
  • Work with and manage relationships with the outsourced vendor so that internal colleagues see you as one seamless team.
  • Sets standards for promotional claims and non-promotional product information sharing; ensuring sponsor partner promotion and communications adhere to regulations and support appropriate use of our medicines in patients as well as driving business goals.  
  • Identify future compliance and quality risks from commercial and promotional innovation within the Therapeutic Area and collaborate with the Global Medical Standards Practice Director in creating effective and practical medical quality policies and standards to ensure continued commercial success in a compliant and ethical manner.
  • Drive continuous quality improvement of Global Brand team outputs by providing consultation and feedback to Brand Teams during concept creation and throughout design and development process whilst ensuring consistency of approval decision-making.  Lead projects/activities relating to standards, covering brand claims supportability, avoiding off-label claims, distinguishing advertising from non-promotional communications, accuracy of promotional and non-promotional medical and product materials. Co-ordinate dissemination of claims updates following challenges to global product claims & support local teams with challenges to competitor labels.

Qualifications

Education and Work Experience:

  •  Higher level degree requirements (R.Ph., PharmD, MD Preferred)
  •  Two years Medical Information experience preferred

Knowledge, Skills, and Abilities:

  • Good working knowledge of appropriate medical information guidelines/regulations
  •  Effective telephone communication and MS Office Suite  skills
  •  Experience with entering data into databases, performing medical literature searches and evaluation of the medical literature.
  •  Strong  medical writing skills required

 PREFERRED:

  • Advanced bioscience or pharmacy/medical qualification with experience of the pharmaceutical industry including medical affairs and compliance.
  • Good scientific understanding of the allocated therapeutic area.
  • Sound knowledge of international medical compliance legislation, codes of practice and their practical application.
  • Knowledge and experience of corporate governance.
  • Knowledge and understanding of the pharmaceutical industry ‘political’ environment and of Sponsor partner as an important and leading player.
  • Experience of successful cross functional and worldwide influencing.
  • Strong independence and credibility.
  • Excellent communication and presentation skills.
  • Strong strategic thinking ability.
  • Strong analytical skills and ability to ascertain the relevant issues from large masses of information.




PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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