- USA Only
- 2 applicants (15%)
Technical Writer – Hybrid/Remote
Minneapolis, Minnesota, United States
Please apply using a laptop or desktop computer.
This position works extensively with internal stakeholders and subject matter experts to write, review, revise and implement standard operating procedures, manuals of operations, and other essential documents to fulfill business requirements, comply with relevant regulatory requirements, and adhere to established NMDP Controlled Document Management System processes. Collaborates with multiple Operations departments and project teams to ensure documents align with actual procedures, best practices and regulatory requirements. This position can be remote (US) or hybrid. #LI-Remote #LI-Hybrid
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- Creates/writes, reviews, edits and updates essential documents (policies, standard operating procedures [SOPs], manual of operations chapters, job aids, forms) for operational units and project teams involved in FDA-regulated biological product manufacturing processes.
- Collaborates with subject matter experts (SME) and other key stakeholders for knowledge transfer of critical information regarding procedural requirements and process steps to be included in SOPs and other essential documents. Where feasible, captures detailed business process flows via process flow diagrams.
- Communicates proactively and frequently with SMEs and other stakeholders to ensure document content revisions are accurate and being met within established timeframes. Schedules stakeholder reviews as appropriate.
- In accordance with NMDP Controlled Document Management System processes, facilitates effective management and control of essential documents to ensure they are clear and accurate; utilize standard terminology and format; are version-controlled; appropriately reviewed and approved; kept secure, confidential and traceable; and archived when obsolete.
- Maintains proficiency in using the MasterControl™ Quality Management Software system that houses the document management module encompassing the “life cycle” of all controlled documents. Proficiency includes ongoing mastery of the Author and Super-User Roles.
- Consults with key QRS staff and other stakeholder experts regarding compliance with applicable standards, regulations and laws pertinent to procedures/documents being created or revised.
- Keeps current and up-to-date with key regulations and standards related to the cellular therapy biological product manufacturing process, particularly in the areas of FDA Good Manufacturing Practice (GMP), Good Tissue Practice (GTP) and Good Documentation Practice (GDP).
Provides Subject Matter Expertise to Process and Project Work:
- Participates in business system and process design sessions that may involve significant document activity, as appropriate.
- Promotes adherence to all provisions and requirements of the NMDP Controlled Document Management System.
- Identifies opportunities for increased efficiencies in producing and implementing technical/controlled documents, as well as opportunities for increased compliance with regulatory requirements.
- Participates on cross-functional teams and projects as delegated.
- Provides excellent and responsive customer service to internal colleagues and external partners.
- Performs all duties in compliance with standard operating procedures, NMDP Standards, relevant FDA regulations, and other applicable Federal, State, and local laws.
- Other duties as assigned.
- Advanced writing skills with proven ability to produce high-quality documentation that conveys complex technical or procedural information clearly, concisely and appropriate for its intended audience; ability to proofread, edit language and improve style consistency.
- Highly proficient in Microsoft Office Suite software applications including Visio; proficiency with document management software.
- Meet deadlines and manage multiple projects and tasks simultaneously.
- Quickly synthesize company technology and terminology; excellent interpersonal and customer service skills; proven ability to work collaboratively and flexibly with subject matter experts and stakeholders across multiple levels of the organization; work both independently and as part of a team.
Education and/or Experience:
- Bachelor’s degree in English, Communications or Technical degree preferred. Certification in technical writing desired.
- Two years of experience creating SOPs, training materials, or other instructional materials. Experience working in a regulated environment and/or biomedical or bioscience field strongly desired.
PREFERRED QUALIFICATIONS:(Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
- Experience with process mapping and gap analysis.
- Number of Openings: 1
- Pay Basis: Yearly
- Schedule: Full-time
- Driver Policy: No