This position is responsible for developing high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products. Works under limited supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.
Major Duties and Responsibilities:
* Writes/edits clinical regulatory and other supporting documents/submissions for assigned studies/indications for one or more programs/molecules, and manages the overall development and approval process. Critically analyzes, synthesizes, and presents complex information from a broad range of scientific disciplines and therapeutic areas.
* Provides first-line review of documents from authors assigned to document deliverables for correctness, clarity, completeness, and compliance.
* Works with service providers/contractors as needed for delivery of assigned documents.
* Contributes to or assists in the preparation of document templates and procedures. Builds cross-functional capabilities by providing writing-related training as needed.
* Supports continuous improvement within the MW group. Uses knowledge and experience to improve document quality and process efficiency. Promotes adherence of documents to MW standards and processes.
* 6+ years experience in the medical/regulatory 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.
* 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.
* Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables. Manages ambiguity and works through conflict to create consensus.
* Ability to identify problems and develop approaches to solving them.
* Ability to effectively communicate in oral presentations.
* Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience.
Biospace : ~BSP
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
My company shares my passion for helping to improve human health around the world.
This is My MedImmune
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.