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.
Summary of Position
Responsible for supporting Clinical Development in clinical protocol development, clinical study reports, Investigator's Brochures, IND/NDA. Supports all clinical writing activities outlined in the Project Clinical Development Plans with minimal direction and guidance. Reviews documents and offers recommendations in the preparation of regulatory documents.
Responsibilities and Job Duties:
- Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation. Ensures documents are written in compliance with all regulations (ICH, GLPs, and GCPs).
- Leads cross-functional delivery of clinical documents to agreed-upon timelines.
- Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, or templates when completing medical writing projects, on-time.
- Compiles, writes, and edits medical writing deliverables, and serves as lead medical writer on inter-department and intra-department project teams with minimal supervision. Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas. Interacts with department head and staff members in clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required
- Supports the development, improvement and maintenance of Departmental Guidelines/SOPs, writing style guides and format, and departmental templates such as, protocols, investigator's brochures, final clinical study reports, IND sections to ensure consistency and departmental compliance.
- Performs on-line clinical literature searches and analysis of data, as requested, including working with EndNote for the management of literature references
- Maintains current knowledge of current industry practices and latest professional, technological, and regulatory developments in medical writing, as well as therapeutic areas and updates and educates team in a timely manner
Education & Credentials
Sr. Medical Writer
- A minimum of 8 years in a pharmaceutical, biotech, or CRO in a medical writing position
- Regulatory writing experience
- Must have experience authoring clinical protocols, protocol amendments, Investigator’s Brochure, and clinical study reports
Principal Medical Writer
- A minimum of 10 years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment
- Must have experience authoring clinical study reports (Phase I through III), protocols, protocol amendments, and Investigator’s Brochure
- Experience with complex submission dossiers such as NDA and/or BLA submissions
- Experience with EDMS systems (e.g. Documentum, Core Dossier, Veeva, etc.)
Knowledge, Skills and Abilities
- Ability to manage large writing projects with minimal supervision
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information
- Must possess excellent grammatical, editorial and proofreading skills and have the ability to interpret and present complex data
- An ability to create effective presentations.
- Ability to coordinate the production of deliverables, manage project timelines, and provide leadership to a project team
- High degree of independence in decision making and problem solving
- Extensive knowledge of English grammar with a familiarity with AMA and/or MLA style guide
- Understanding of FDA and ICH regulations and guidelines.
- Strong knowledge of eCTD templates (e.g. ISI writer, Liquent Smart Desk, or other document formatting tool)
- Proficient with MS Word and a working knowledge of Excel, Project, and Power point.
- Experience in Oncology
- Experience with EDMS (e.g. Documentum, Core Dossier, Veeva)
- Advanced degree a plus.