Associate medical writer
Us remote worker
The emmes company, llc (“emmes) is a global, full-service clinical research organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovationWe believe in the power of truth, so much so that we named our company emmes, which means truthThrough decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our “character achieves results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: integrity, agility, passion for excellence, collaborative partnerships and intellectual curiosityWe are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! you will be joining a collaborative culture that empowers every emmes employee — from entry level through top executive — to contribute to our clients’ success by sharing ideas openly and honestly.
Primary purpose
The associate medical writer, under supervision of senior writers provides writing assistance, revises, edits, and performs quality control for clinical regulatory and scientific communications documents.
Responsibilities
Contributes to the development of documents for regulatory submissions, including but not limited to investigator brochures, protocols, device summaries, clinical study reports, and safety reports for assigned projects under the direction of senior writers
Participates in document review meetings with internal teams to ensure issues are resolved
Ability to work collaboratively to resolve comments and produce a final high-quality document under the supervision of senior writers
Provides quality control review of various regulatory and medical communications documents and reviews draft publications for accuracy and continuity with previously published work and submitted regulatory documents
Develops an understanding of us and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions
Contributes to the overall development and approval process for assigned documents within timelines, including documentation generation, initiation of review process, discussions on proposed revisions, and document completion in collaboration with other study team members under the direction of senior staff.
Contributes to the development of processes and tools for the medical writing group
Contributes to medical writing on project teams and participates in interactions including provision of scientific background information as needed
Develops and maintains current therapeutic and project operation knowledge
Work with internal teams to conduct literature searches, contribute to literature reports, the literature database, and contributes to the preparation of literature reviews
Other duties as assigned
Experience
Bs/ba/ms/ma degree (prefer in scientific or health-related field)
Familiarity with relevant software and technology ms office (word, excel, powerpoint, outlook), sharepoint, adobe acrobat, endnote, and ectd authoring templates
Ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data
Demonstrated knowledge and use of medical terminology and/or research methodology
Demonstrated problem-solving skills allowing analysis, synthesis and compilation of data from a broad range of disciplines
Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
Ability to work in a fast-paced, cohesive, collaborative team-oriented work environment
Why work at emmes?
At emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our emmes cares community engagement programWe offer a competitive benefits package focused on the health and needs of our growing workforce, including:
Unlimited approved leave
Tuition reimbursement
401k & profit sharing plan
Work from home anywhere in the us
Maternal/paternal leave
Casual dress code & work environment
Connect with us!
The emmes company, llc is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practicesAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
