Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary

Grifols Diagnostic Solutions is seeking a Senior Technical Document Editor to help support our Labeling department in San Diego, CA. This position will provide formatting and maintenance of technical documentation in support of instrument and software operator manuals, package inserts, SOPs, specifications and training materials.

Primary Responsibilities for Role

• Provide strategic direction and mentorship to other technical editors in the team, fostering a culture of excellence, collaboration and continuous improvement

• Lead the entire process of acquiring translated package inserts and operator manuals by communicating objectives and timelines with external vendors for translation projects, reviewing and approving translated documents upon receipt, acquisition of the Certificate of Translation for compliance, and submission of all relevant documentation to be made effective in the eDMS upon completion of the translation project

• Lead reviews and presentations to project teams, internal and external stakeholders, and regulatory authorities as required

• Manages labeling change requests, creates and implements templates, style guides, and documentation standards to ensure consistency and quality across all technical documentation, submits finalized documentation for review and approval from internal departments

• Execute on project management tracking and priorities by keeping internal trackers and databases up to date, partnering with stakeholders to provide and maintain accurate data, ensuring deadlines and deliverables are met on time

• Edit and maintain technical documentation including operator manuals, package inserts, and regulatory submission documents in compliance with regulatory requirements and company standards

• Edit documents to support Labeling Development in compliance with ISO, cGMP, EU MDR and FDA guidelines, working within established formats and templates

• Identify and inform areas for improvement to Labeling processes, styles, formats, and participate/support in execution of continuous improvement initiatives as appropriate

• Represent Labeling Development on Core Teams and collaborate closely with cross-functional teams including Regulatory Affairs, Marketing, Research & Development Instruments, Product Support and Quality Assurance to understand project requirements and ensure alignment on editing timelines

• Revise documentation as requested by stakeholders

• Manage documentation, including version control, review and approvals process, generating clean and redlined drafts in accordance with established procedures

• Manage the creation, review, approval, distribution, and archival of all controlled documents within Labeling Development, including label and packaging artwork and drawings, package inserts, operator's manuals, work instructions, SOPs, forms, and quality records

• Maintain document repositories and electronic document management systems (eDMS), ensuring accurate document metadata, version control, and document history

• Collaborate in-person with cross-functional departments to mitigate operational constraints (batch record discrepancies, GDP errors etc.)

• Assist in-person demonstrations related to content of technical documents, especially for instrument and software documentation

Additional Responsibilities

• Organize and maintain department files, databases and spreadsheets

• Support and execute on Change Control processes in a timely manner

• Develop comprehensive project plans, outlining key milestones, deliverables and resource requirements

• Oversee the management of technical documentation, version control, and archival processes for all files owned by Labeling Development

• Act as SME for on-site audits and inspections by providing documentation and participating in discussions with auditors as required

• Stay informed about industry trends, best practices and regulatory updates related to technical editing and apply knowledge to continuous improvement initiatives

Knowledge, Skills and Abilities

• Expert proficiency in document authoring and publishing tools such as Adobe FrameMaker, Microsoft Word and/or Madcap Flare, and content management systems. Experience must be current and used in a professional setting

• Strong proficiency in Microsoft Office applications, particularly Word, Excel, and SharePoint

• Strong proficiency in editing and proof-reading technical documents, with excellent grammar, punctuation, and clarity

• Working knowledge with electronic document management systems (eDMS) such as Documentum, LSQM, MasterControl, and document control software

• Working knowledge of MRP and/or ERP systems such as SAP, Axapta, Microsoft Dynamics

• Excellent organizational skills and attention to detail

• Strong communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders

• Working knowledge of quality management systems (QMS) and audit processes

• Understanding of Change Request processes (ECRs, ECOs) for material management impacted by document control changes

• Excellent written and oral communication, and editorial skills

• Strong understanding of regulatory requirements for medical device documentation (e.g., FDA 21 CFR Part 820, ISO 13485)

• Strong conceptual thinking and problem-solving skills, with the ability to translate complex information into clear and comprehensive understanding

• Ability to effectively influence and collaborate with diverse stakeholders

• Proven track record of leadership and project management in a technical role

• Exceptional organizational skills and the ability to prioritize and manage multiple high-level projects simultaneously

Education

Bachelors degree in a relevant field or equivalency. Advanced certifications, such as Certified Professional Technical Communicator (CPTC), will also be strongly considered

Experience

• 5 - 6 years’ experience in editing technical documentation

• 1+ year of prior experience working in a regulated environment

• Working knowledge and experience with graphic design software and multimedia tools is a plus

Equivalency

9+ years of direct experience in lieu of education and experience, preferably in the medical device or pharmaceutical industry

Occupational Demands

Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Pay Scale

The estimated pay scale for a Senior Technical Document Editor role based in San Diego, California is $84,696.35 to $127,045.10. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Currently, the first year PTO accrual for this role is 120 hours per year. Then, after completion of 365 days of employment PTO accrual for this role will increase to 160 hours per year. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 518539

Type: Regular Full-Time

Job Category: Others