Principal Medical Communications Scientist (Regulatory Medical Writer)

  • Company: MedImmune
  • Location: Gaithersburg, Maryland
  • Posted: October 12, 2017
  • Reference ID: R-014516
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 Scientist 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.
Are you ready for a challenging, strategic position in medical writing?
As a Principal Medical Communications Scientist (MCS) at AstraZeneca , you'll play a pivotal role in developing new medicines that make a positive impact on patients' lives. Working in our Global Medicines Development organization, you will lead the communication of clinical submissions for marketing approval (NDAs/BLAs/MAAs), transforming our exciting pipeline of novel small and large molecules into valued new medicines in oncology, respiratory and cardiovascular indications. You will join us at one of our worldwide research bases (Gaithersburg, MD), where you'll thrive in a culture of scientific excellence and collaboration. And you'll join a world-class team of Medical Communication Scientists - our group has an outstanding record of efficiently driving strategic communications excellence in project teams to achieve successful submissions and approvals.
Main Duties and Responsibilities
As a Principal MCS, you will
  • Provide expert communications leadership to late-stage drug projects (Phase 3 onwards) in a world-leading biopharmaceutical company
  • Lead a strategy-driven approach to authoring clinical documents for submissions. You will liaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing information. You will represent Medical Communications Science on the high-level, cross-functional submission team
  • Author the most complex and important documents for the submission yourself (Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees)
  • Lead a team of internal Medical Communications Scientists, and/or external medical writers, to deliver the other clinical submission documents to time, cost and quality
  • Collaborate with your Therapy Area Leader in Medical Communications Science to develop resourcing strategies
  • Develop and implement new best practices in communication and submission development, and train and develop less experienced Medical Communication Scientists.
Essential Requirements and Experience
You will need:
  • Minimally a Bachelor's degree in the life sciences; MSc or PhD preferred
  • A significant track record of successfully leading the communications aspects of complex marketing application submissions (NDA/BLA/MAA) for late stage drug projects
  • Experience in leading a strategy-driven, label-focused approach to planning and development of submissions
  • Experience in bringing expert communications leadership to submission teams
  • Extensive experience as lead author of clinical-regulatory documents and submissions, including Clinical Overviews and Clinical Summaries (CTD Modules 2.5 and 2.7), strategic briefing documents, Advisory Committee briefing documents, etc.
  • A track record of successful partnering with external medical writing vendors to ensure delivery of clinical documents to time, cost and quality
  • A history of mentoring and coaching less experienced Medical Communications Scientists or similar staff
  • Proven capability in Medical Communications Science as a discipline, and a track record of furthering the discipline by development of best practices
  • Willingness to undertake domestic and international travel as required
Required capabilities
Principal MCSs are role models for the MCS group, both within the group itself and in cross-functional submission teams for a drug project. You should have the following skills:
  • Communication Skills - Strong communication skills, both written and oral. Expertise in knowing, applying and developing robust communication processes and standards to ensure the efficient delivery, quality and compliance of clinical regulatory documentation
  • Project and Self-Management Skills - Proven ability to get things done and deliver in a complex environment (high visibility, deadlines, accelerated timelines). Ability to work with vendors to deliver. Proactivity, flexibility, agility and resilience to thrive in a rapid-paced environment. Ability to adapt to a changing regulatory and communications environment
  • People Skills - Collaboration skills, strong negotiation and interpersonal skills, high ethical standards
  • Thinking Skills - Strong strategic and scientific skills. Ability to integrate information from all phases of drug development into filings, ensuring support of the label
  • Expert Leadership - Ability and self-confidence to provide guidance and challenge to ensure optimal communication in support of the label, in light of emerging data. Ability to develop others (coaching, mentoring, role modeling) in the discipline of Medical Communications Science
  • Knowledge of Drug Development - Strong knowledge of drug development, regulatory guidelines and reviewers' expectations.
Next Steps
If you are looking for an exciting opportunity in strategic communications leadership, apply today! To be considered, please complete the full application on our website at your earliest convenience - this application is the only way that our Recruiter and Hiring Manager can determine your qualifications for this opportunity. If you know someone else 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

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