Senior Medical Writer

Location
Tarrytown, NY, United States
Posted
Apr 11, 2021
Ref
24013BR
Required Education
Other
Position Type
Full time
The Senior Medical Writer will be responsible for tracking his/her own writing projects, and for knowing, understanding, and ensuring adherence to regulatory guidelines and department document standards. We also expected you to ensure maintenance of document standardization through use of model documents/templates and appropriate peer review. You will be reviewing documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR. You will be collaborating closely with the appropriate matrixed team members to craft and review content of documents, and to follow up with other functional groups for materials needed for document completion. You will work independently writing CSRs, CSPs, CSP amendments, and ICFs in a variety of therapeutic areas. Training on Clinical Summaries and other regulatory documents may be provided.
In this role, a typical day might include the following:
  • Clinical Study Protocol Amendments, Clinical Study Reports, Informed Consent Forms, and Patient Safety Narratives. Opportunities to write or contribute to other Regulatory documents such as Clinical Summaries and Briefing Documents may be provided.
  • We expect you will represent Medical Writing at cross-company and TA meetings.
  • Drive document development meetings.
  • Articulate document strategy and timelines.
  • Be able to identify the accurate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss.
  • Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
  • Lead processes and organize priorities; Tackle problems; Foster collaboration to resolve issues.
  • Experience writing in plain language style (for ICFs)
  • Ability to explain sophisticated medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience.
  • Familiarity with ICH GCP guidelines for informed consent considered a plus
  • This role might be for you if:
  • We seek a Bachelor's degree (advanced degree preferred).
  • We look for a Minimum of 7+ years of proven experience to include a minimum of 5+ years of Medical Writing experience.
  • Have written CSRs, clinical protocols, clinical protocol amendments, patient narratives, and ICFs
  • Provide appropriate input on others' documents, including review of key contributing documents, such as the SAP
  • Proactively identify and lead projects, requiring some but not significant guidance
  • Take ownership for your professional development
  • Have the ability to comprehend key points of meetings and interactions, and follows up when necessary
  • Follow agendas for meetings; Take action and produces quality written work product
  • Be able to balance multiple priorities and adapt quickly to new situations and new project demands
  • Advances conflict appropriately
  • Have a good working knowledge of PDF, and Project. Skilled in use of MS WORD. Have used 1 or more EDM systems

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.