Job details
Job type full-time
Full job description
Job title: associate principal/associate director medical communications specialist (clinical regulatory medical writer/submission lead)
Location: gaithersburg, md
At astrazeneca we work together across global boundaries to make an impact and find answers to challengesWe do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thingWe 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 the associate principal/associate director medical communications specialist (clinical regulatory medical writer/submission lead), you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ livesYou will help drive 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 associate principal/associate director medical communications specialist (clinical regulatory medical writer/submission lead) at astrazeneca, you’ll play a pivotal role in developing new medicines that make a positive impact on patients’ livesWorking 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 indicationsYou will join us at one of our worldwide research bases (gaithersburg, md), where you`ll thrive in a culture of scientific excellence and collaborationAnd 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
Create clinical submission communication strategies
Lead development of the clinical submission communication strategy for a new product, liaising with senior project staff
Prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported
Build and deliver clinical-regulatory submissions and defence
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 complex and important documents (eg, clinical overviews, briefing documents for regulatory authorities and advisory committees)
Drive continuous improvement and operational excellence from a communications leadership perspective
Develop and implement new best practices in communication and submission development
Train and develop less experienced medical communication science staff
Essential requirements:
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 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.
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.
As a medical writer you should have the following skills and abilities:
Communication skills – strong communication skills, both written and oralExpertise 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 deliverProactivity, flexibility, agility and resilience to thrive in a rapid-paced environmentAbility 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 skillsAbility 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 dataAbility 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.
Astrazeneca has taken critical steps to protecting colleagues, loved ones, and patients from covid-19 and its variantsCovid-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.
Remote options could be considered
For job holders working remotely, we would expect you to
Be willing to travel to an az site for business-critical meetings (you and your line manager would discuss the need for this beforehand, and astrazeneca would pay for any such travel)
Have a dedicated home workspace with fast broadband
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 opportunityIf you know someone else who would be a great fit, please share this posting with them.
