Senior Staff Technical Publications Specialist

Work Flexibility: Remote or Hybrid or Onsite

Position Summary

Assists in the timely development and completion of IFUs, PILs, artwork, labels, package inserts, clinical reports, summary documents, and other documents both in physical and electronic formats. May oversee the electronic regulatory submission process. Oversees and provides recommendations for the development of formats and guidelines for documentation. Provides guidance and direction for completion and development of clinical and pre-clinical documents. Ensures effective planning and management of timelines for all aspects of technical documents.

This is a highly specialized individual contributor role that requires deep expertise from a professional / technical thought leader in their respective field or discipline. The role requires expertise within a discipline in a specialized field. The job provides technical guidance and direction for his/ her area of specialization. The job requires good analytical skills as well as evaluative judgement based on the analysis of factual and qualitative information in complicated or novel situations. The complexity implied at this level of problem solving relates to the ability to filter, prioritize, analyze and validate potentially complex and dynamic material.

General Requirements

• Excellent interpersonal communication and collaborative teamwork skills

• Ability to communicate effectively with team members, management, and subject-matter experts.

• Utilize proper software to maintain project records such as PPM system, MS Office or SharePoint.

• Technical aptitude for systems and tools and analytical thinking

• Well organized, able to support multiple projects. Project management skills. Able to meet deadlines.

• Lead Global, Divisional or cross functional projects

• Ability to generate and explain detailed schedules and performance objective

• Demonstrated experience in presenting to mid-level management

• Subject matter expert for the regulatory and Stryker-business requirements of their area of ownership

• Customer service oriented. Able to work with internal teams and external services.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Key Areas of Responsibilities:

• Work is performed without appreciable direction.  Exercises considerable latitude in determining technical objective of assignment.  Provides leadership and training of new procedures, standards, requirements to all level professional employees.

• Having wide-ranging experience, applies extensive technical expertise, and has knowledge of other related disciplines.  Knowledge of standards and requirements associated with labelling.

• Must be highly engaged with team and success of team goals. 

• Influences beyond the department. Would engage regularly with Corporate initiatives and support complex technical IT architectural solutions for Labelling tools and processes. Communicates back to divisions. Leads development of process solutions for cross functional groups. Analysis of business cases with return on investment/time.

• Supports gap analysis, innovation, strategic initiatives – process improvements.

• Aware of cultural differences that may exist in regulatory requirements and technical practices. See impact of new and changing requirements. Spread awareness of country-specific needs. Provides accurate estimates on cost and time impact. (Monitor and communicate global regulatory needs to larger NPD teams. Cross cultural communication) Opportunity to work with various global teams.

• In depth knowledge of divisional products/processes such as risk management, and business processes (packaging, clinical sciences, regulations, etc).

• Networks with others cross-divisionally in area of ex