Job title: Clinical Regulatory Medical Writer / Medical Communication Scientist (MCS),

Location: Gaithersburg, MD preferred, Remote potential!

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 the Clinical Regulatory Medical Writer / Medical Communication Scientist (MCS), you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. You 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 Clinical Regulatory Medical Writer / 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

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 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.

Accepting applications until August 9th, 2020

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

Date Posted

Closing Date

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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.