MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Serve as subject matter expert on clinical protocols, protocol amendments, clinical study reports, and Investigator's Brochures. Provide guidance on document strategy for more complex dossiers associated with regulatory submissions, including IND and BLA filings. Work collaboratively with cross-functional teams to meet project goals. Ability to recognize and resolve resourcing or scheduling conflicts across project assignments. Assist in management and oversight of external vendors, including contract medical writers, QC reviewers, and document formatters. Assist with development of operational process improvements, including development of medical writing work process documents, SOP updates and document templates.
Responsibilities and Job Duties:
Additional Responsibilities for Principal Medical Writer:
Education & Credentials
Bachelor’s degree required
Sr. Medical Writer:
Principal Medical Writer:
Knowledge, Skills and Abilities
MS, MA, or PhD in a science-related area
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
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