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Senior/Principal Medical Writer

Senior/Principal Medical Writer

ID 
2018-1168
Category 
Clinical Development
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

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

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:

  • Serve as lead medical writer in authoring clinical regulatory documents, specifically CSRs
  • Represent medical writing in cross-functional team meetings
  • Collaborate with department heads and staff members of cross-functional groups, including clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables according to agreed-upon timelines
  • Adhere to established regulatory standards, including ICH-E3 guidelines and company Standard Operating Procedures
  • Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency
  • Support the development, improvement and maintenance of Medical Writing work practice documents, standard operating procedures, and document templates to ensure consistency and departmental efficiency
  • Perform on-line literature searches, and use of EndNote for the management of literature references and bibliographies
  • Maintain current knowledge of industry trends and best practices in medical writing.

Additional Responsibilities for Principal Medical Writer:

  • Serves as subject matter expert in preparing clinical regulatory documents through all phases of development
  • Oversight of external vendors, including contract writers, QC reviewers, and document formatters.

 

Qualifications

Education & Credentials

 

Bachelor’s degree required

 

Experience

Sr. Medical Writer:

  • A minimum of 8 years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment
  • Must have experience authoring clinical study reports, protocols, protocol amendments, and Investigator’s Brochure
  • Experience with EDMS systems (e.g. Documentum, Core Dossier, Veeva, etc.)

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

  • Project management skills with ability to manage complex writing projects with minimal supervision
  • Must possess editorial and proofreading skills
  • Ability to interpret and present complex data
  • Must be highly detail oriented
  • Ability to create effective presentations
  • Ability to coordinate the production of deliverables, manage project timelines, and provide leadership to project teams
  • High degree of independence in decision making and problem solving
  • Effective use of English grammar and usage standards
  • Understanding of FDA and ICH regulations and guidelines
  • Familiarity with eCTD templates, e.g. ISI writer, Liquent Smart Desk, or other document formatting tools
  • Proficient with MS Office software, including Word, Excel, Project, and Power point.

Supervisory Responsibilities

None

Preferred Qualifications

MS, MA, or PhD in a science-related area

 

Statement

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 info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.