Job Description
Legend Biotech is seeking a Senior Medical Writer as part of the Clinical Development team based Remote.
Key Responsibilities
- Preparation of:
- Initial Investigational New Drug (IND) applications and amendments
- Clinical study protocols and protocol amendments
- Investigator brochures and updates
- Interim and final clinical study reports
- IND annual report / development safety update reports
- Patient informed consent forms - Other writing responsibilities include abstracts, posters, presentations, manuscripts (papers for peer reviewed medical journals), slide decks, conference reports, etc.
- Provide guidance and support to other cross functional teams in preparation or review of scientific content
Requirements
- Experience in oncology and 5-10 years experience in industry
- Familiarity with drug development, biostatistics, pharmacology, clinical trial methodology
- Ability to meet deadlines and be results-oriented
- Ability to manage and prioritize multiple projects simultaneously
- Function as a team-player, highly organized, self-motivated, and extremely detail-oriented
- Strong communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite (word, powerpoint, excel, etc)
#Li-JK1
#Li-Remote
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
Legend Biotech is seeking a Senior Medical Writer as part of the Clinical Development team based Remote.
Key Responsibilities
- Preparation of:
- Initial Investigational New Drug (IND) applications and amendments
- Clinical study protocols and protocol amendments
- Investigator brochures and updates
- Interim and final clinical study reports
- IND annual report / development safety update reports
- Patient informed consent forms - Other writing responsibilities include abstracts, posters, presentations, manuscripts (papers for peer reviewed medical journals), slide decks, conference reports, etc.
- Provide guidance and support to other cross functional teams in preparation or review of scientific content
Requirements
- Experience in oncology and 5-10 years experience in industry
- Familiarity with drug development, biostatistics, pharmacology, clinical trial methodology
- Ability to meet deadlines and be results-oriented
- Ability to manage and prioritize multiple projects simultaneously
- Function as a team-player, highly organized, self-motivated, and extremely detail-oriented
- Strong communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite (word, powerpoint, excel, etc)
#Li-JK1
#Li-Remote
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
About Legend Biotech USA
Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 1,000 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.
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