Associate Principal/Associate Director Medical Communications Specialist (Clinical Regulatory Medical Writer/Submission Lead)

Gaithersburg, Maryland

Posted in Pharmaceuticals

This job has expired.

Job Info

Diverse Minds. Bold Disruptors. Meaningful Impact.

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 extraordinary medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.

We are hiring for an Associate Principal/Associate Director Clinical Regulatory Medical Writer/Submission Lead! In this role, you will be channeling our scientific capabilities to make a positive impact on changing patients' lives. You will help drive late-stage development of our innovative pipeline, redefining exciting science into valued new medicines, and ensuring patients around the world can access them.

Are you ready for an exciting, strategic position in clinical regulatory medical writing?

Working in our Global Medicines Development organization, you will be leading the way for the communication of clinical submissions for marketing approval (NDAs/BLAs/MAAs), redefining our exciting pipeline of novel small and large molecules into valued new medicines in oncology, respiratory and cardiovascular indications. Join us at one of our worldwide research bases in Gaithersburg, MD and thrive in our scientific excellence and collaboration. Be a part on an extraordinary team of Medical Communication Scientists - our group has an outstanding record of efficiently driving crucial communications excellence in project teams to achieve successful submissions and approvals!

Main Duties and Responsibilities-

Build and Deliver Clinical-Regulatory Submissions:

  • Collaborate with the TA Head and MCS authoring team leader to develop resourcing strategies
  • Lead a team of authors (internal and external) to deliver clinical contribution to a submission
  • Ensure alignment of clinical submission documents with the proposed prescribing information
  • Represent Medical Communications on the high-level, cross-functional submission team
  • Author documents that facilitate efficient evaluation and approval by health authorities
  • Author the most sophisticated and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees)

Create Clinical Submission Communication Strategies:
  • Lead development of the clinical submission communication strategy for a new product, collaborating closely with senior project staff
  • Prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported

Drive Continuous Improvement and Operational Excellence from a Communications Leadership Perspective:
  • Develop and implement new standard methodologies in communication and submission development
  • Train and develop Medical Communication Science staff

  • Minimally a Bachelor's degree in the life sciences; MSc or PhD preferred
  • Minimum of two years' experience within the pharmaceutical/medical industry/CRO
  • Broad solid understanding of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical-regulatory documents/submissions.
  • Knowledge of Drug Development - Solid understanding of drug development, regulatory guidelines and reviewers' expectations.
  • Ability to work well with vendors
  • Extensive knowledge of current regulatory guidelines relating to regulatory communications.
  • Excellent communication skills.
  • 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.
  • May act as a global lead, authoring complex documents, coordinating authoring teams to deliver in line with project strategy, ensuring quality and efficiency in delivery, establishing communication standards and best practice within a project team
  • Willingness to undertake domestic and international travel as required by the project.

Desirable 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 - Shown 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 in a rapid-paced environment. Ability to adapt to a changing and evolving 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 subject area of Medical Communications Science

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

Next Steps

The recruitment process will follow the below steps:
  • Application, Resume, and motivational letter review
  • If qualified, 30 minute screening call with a senior member of the team
  • Completion of a medical writing exercise
  • Informal meeting of various team members
  • Final interview
Please make sure to include resume and motivational letter.

Find out more:

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

    This job has expired.

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