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Senior Process Writer - Process & Procedures - CONTRACTOR

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Dec 29, 2021

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Job Details

The Global Development Process & Procedures (P&P) Process Writer is responsible for project facilitation and creation of Global Development process documents in collaboration with Process Owners and Subject Matter Authorities.

In this role, a typical day might include:
  • Handling and leading projects for the development of procedural documents for global development by:
  • Assessing how the creation or update of procedural documents impacts other procedural documents through the management of document Impact Assessments.
  • Identifying the partners/SMEs and ensuring they are engaged in the content development/revision activities, including review and approval cycles.
  • Leading the Technical Writing of Global Development procedural documents in collaboration with functional process owner and cross-functional SME(s) by translating sophisticated cross-functional concepts to process maps and documentation ensuring any open process deviations, inspection commitments, corrective/ preventative actions and critical gaps are addressed.
  • Facilitating process mapping activities collecting process details (scope, boundaries, inputs, outputs, process steps and sequence) while allowing for the visualization of data flows, identification of bottlenecks and waste, and minimizing redundancies.
  • Facilitating the adjudication of comments from documentation reviews.
  • Collaborating with Quality Managers during content development to ensure alignment with Content Standards and Lean Writing Principles.
  • Leading document review and approval workflows.
  • Chipping in to P&P improvements as applicable.
  • Maintaining project schedule, identifying and mitigating risks or issues, raising to leadership as applicable.
  • Collaborating with Global Development Training, Change Management, and GD Quality when applicable, to support process implementation.

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.

This role may be for you if:
  • You have the ability to understand and discuss sophisticated information with people of diverse occupational backgrounds.
  • You have the ability to understand and translate sophisticated processes into lean processes.
  • You have experience in Microsoft Visio or other process mapping tools.
  • You have excellent written and verbal communication skills.
  • You have the ability to write in explanatory and procedural styles for multiple audiences.
  • You have experience in controlled procedural document principles, process design and leading process improvements.
  • You have the shown ability to craft/develop SOPs, supporting documents and forms/templates through writing samples.
  • You are aware of GCP and GVP regulatory requirements.
  • You demonstrate strong influencing and negotiating skills with the ability to communicate optimally at all levels of the organization.
  • You demonstrate skills in problem solving, working independently and in a team environment.

To be considered, you must have a BS/BA Degree with 6+ years shown experience. MS degree and 4+ years shown experience. You'll need at least 7 years experience in a global regulated organization, or a minimum 5 years’ working in a technical writing position.

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

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