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 Experts.
- Manages and leads 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 stakeholders/SMEs and ensures they are engaged in the content development/revision activities, including review and approval cycles.
- Lead the Technical Writing of Global Development procedural documents in collaboration with functional process owner and cross-functional SME(s) by translating complex cross-functional concepts to process maps and documentation ensuring any open process deviations, inspection commitments, corrective/ preventative actions and critical gaps are addressed.
- Facilitate process mapping activities capturing 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. Identify and evaluate issues and/or gaps in processes and propose effective resolutions.
- Facilitate the adjudication of comments from documentation reviews.
- Collaborate with Quality Managers during content development to ensure alignment with Content Standards and Lean Writing Principles
- Manage document review and approval workflows.
- Maintain project schedule, identifying and mitigating risks or issues, escalating to leadership as applicable.
- Contribute to P&P improvements as applicable.
- Collaborates with Global Development Training, Change Management, and GD Quality when applicable, to support process implementation
- Other duties, as assigned.
- May require up to 25% travel
List knowledge, skills, and abilities required to perform the job.
List any preferred job requirements as well.
- Minimum 7 years’ experience in a global regulated organization
- Minimum 5 years’ working in a technical writing position
- Ability to understand and discuss complex information with people of diverse occupational backgrounds
- Ability to understand and translate complex processes into lean processes
- Experience in Microsoft Visio or other process mapping tools
- Excellent written and verbal communication skills
- Analytical and critical thinking
- Strong attention to detail
- Ability to actively listen
- Ability to write in explanatory and procedural styles for multiple audiences
- Experience in controlled procedural document principles, process design and leading process improvements
- Proven ability to design/develop SOPs, supporting documents and forms/templates through writing samples
- Awareness of GCP and GVP regulatory requirements
- Strong leadership, organizational and project management skills
- Demonstrates strong influencing and negotiating skills with the ability to communicate effectively at all levels of the organization
- Demonstrates skills in problem solving, working independently and in a team environment
- Experience using Electronic Document Management systems is preferred
- Ability to multi-task and manage conflicting/changing priorities
Core Behavioral Competencies:
- Stakeholder Management
- Project Management
- Process Management
- Strategic Thinking
- Critical Thinking & Problem Solving
- Integrity and Trust
- Organizational & Political Savvy
- Dealing with ambiguity & paradox
Minimal educational requirements:
If years of experience in lieu of a college degree is also acceptable, please list number of years required
Equivalent experience (include # of years) in lieu of degree
High School Diploma
Board Certified MD
Required Licenses & Certificates:
Minimum Years of Experience:
BS/BA Degree with 6+ year’s relevant experience. MS degree and 4+ year’s relevant experience.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.