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Location:
Gaithersburg, Maryland, United States
Job reference: R-032776
Posted date: Nov. 12, 2018
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If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health and help fight and cure disease.  As a Lead Medical Writer/Sr Medical Writer in Gaithersburg, MD or Cambridge, UK you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Main Duties and Responsibilities

As the Lead Medical Writer/Sr Medical Writer, you will be responsible for developing high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products, working under limited supervision (Lead MW) or independently (Principal MW) to manage and prioritize work to ensure deliverables are completed per time and quality goals.

As the Lead Medical Writer, you will:

  • Write clinical regulatory documents/submissions for assigned studies over multiple programs and indications.
  • Manage the overall development and approval process.
  • Critically analyzes, synthesizes, and presents complex information from a broad range of scientific disciplines and therapeutic areas. 
  • Provide first-line review of documents.
  • Work with service providers/contractors as needed for delivery of assigned documents.
  • Contribute to or assists in the preparation of document templates and procedures.
  • Builds cross-functional capabilities by providing writing-related training as needed.
  • Support continuous improvement within the MW group.
  • Uses knowledge and experience to improve document quality and process efficiency.

As the Sr Medical Writer, you will:

  • Lead the writing/editing and overall development and approval process for clinical regulatory and other supporting documents/submissions for assigned programs/molecules.
  • Critically analyzes, synthesizes, and presents complex information from a broad range of scientific disciplines and therapeutic areas.  
  • Provide critical review of documents.
  • Drive consistency across projects/programs.
  • Manage service providers/contractors as needed.
  • Lead continuous improvement within the department and across the organization.
  • Use submissions-related expertise to improve document quality and process efficiency.
  • Ensure adherence of documents to MW standards and processes.
  • Build cross-functional capabilities by providing writing-related training as needed.
  • Mentor staff and foster high performance through motivation of individuals and teams.

Essential Requirements

Lead Medical Writer:

  • 6+ years experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment.
  • Includes proficiency at authoring/editing CSRs, experience authoring/editing multiple other types of clinical regulatory documents (eg, study level, program level, health authority responses), and knowledge of multiple therapeutic areas, disease areas, and technical disciplines.
  • Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables.
  • Ability to effectively communicate in oral presentations. 
  • Ability to identify problems and develop approaches to solving them.
  • Manages ambiguity and works through conflict to create consensus.

Senior Medical Writer:

  • 8+ years experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment.
  • Includes proficiency at authoring/editing CSRs, experience authoring/editing multiple other types of clinical regulatory documents (eg, study level, program level, health authority responses), and knowledge of multiple therapeutic areas, disease areas, and technical disciplines.
  • Ability to work effectively and collaboratively to influence team strategy and solve complex problems.
  • Demonstrates excellent communication skills.
  • Encourages a team environment that reinforces open dialogue and diversity of thought and opinion.
  • Deals effectively with ambiguity and works through conflict to create consensus.

For both:

  • Requires PhD/PharmD or a Master’s degree in a scientific discipline

Desirable Requirements

  • Proficiency in the use of Microsoft Office applications and working in electronic document management systems. Extremely high attention to detail.
  • Thorough knowledge of the drug development process with an understanding of the strategy for regulatory submissions. Knowledge and understanding of the principles of GXP, ICH, CTD and other global standards. Understanding of interdependencies among projects within and across programs. Background in biologics a plus.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone 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 lawAstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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Senior/Lead Medical Writer
MedImmune

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