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Senior Medical Writer

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

5-10 years of industry experience, Experience in oncology, Familiarity with drug development and biostatistics, Advanced computer literacy of MS Office Suite.

Key responsabilities:

Prepare IND applications and amendments
Provide guidance to cross-functional teams

Legend Biotech Scaleup https://legendbiotech.com/

1001 - 5000 Employees

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Job description

Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

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)

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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.