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Senior Medical Writer - Temp

Employer
Regeneron Pharmaceuticals, Inc.
Location
Working from Home
Start date
Aug 6, 2022

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Job Details

In this role, a typical day might include the following:

  • Working with the clinical team, the Senior Medical Writer will be responsible for writing Clinical Study Protocols, 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. 
  • Represent medical Writing at cross-company and TA meetings.
    • Drive document development meetings;
    • Articulate document strategy and timelines;
    • Be able to identify the correct 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. 
  • Manage processes and organize priorities; Solve problems; Foster collaboration to resolve conflict
  • Experience writing in plain language style (for ICFs)
  • Ability to explain complex 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:

  • Bachelor's degree (advanced degree preferred)
  • Minimum of 7+ years of industry experience to include a minimum of 5+ years of Medical Writing experience.
  • Have written CSRs, clinical protocols, clinical protocol amendments, patient narratives, and ICFs
  • Have the ability to work independently
  • Provide appropriate input on others’ documents, including review of key contributing documents, such as the SAP
  • Proactively identify and manage projects, requiring some but not significant guidance
  • Be a team player
  • Take responsibility for his/her own 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 juggle multiple priorities and adapt quickly to new situations and new project demands
  • Escalates 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.

    Company

    Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
     
    Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

    Stock Symbol: REGN

    Stock Exchange: NASDAQ

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    Find Us
    Website
    Phone
    914-847-7000
    Location
    Corporate Headquarters
    777 Old Saw Mill River Road
    Tarrytown
    New York
    10591
    United States
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