Planet Pharma · 2 days ago
Technical Writer
San Diego, CA
Full-time
Onsite
Senior Level
5+ years expPlanet Pharma is a medical device company seeking a Senior Technical Writer. The role involves developing, writing, and maintaining comprehensive technical documentation for Class II medical devices while ensuring compliance with regulatory requirements and industry standards.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Arlene Shiner
Responsibilities
Create, edit, and maintain customer and internal facing technical documentation, including user manuals, installation guides, troubleshooting guide, upgrade/downgrade instructions for various country regulatory submissions
Ensure all documentation meets regulatory requirements, industry standards, and company policies. Create illustrations, flow charts, diagrams, line art, in addition to product photos for both quality and technical documentation. Provide recommendations to engineers on optimizing engineering data expressed in graphs, illustrations, and tables to ensure clarity and consistency
Collaborate with engineering, quality assurance, regulatory affairs, clinical/medical affairs, marketing, customer support, and other departments to gather information and ensure accuracy and completeness of documentation and to suggest changes to enhance a document's readability, clarity, conciseness, and style. Also collaborate with subject matter experts in the review and development of instructions-for-use (IFU) design specifications as part of the product’s quality documentation
Review and edit technical documents for clarity, accuracy, and compliance
Develop and implement documentation standards, best practices, and style guides to ensure consistency and quality
Communicate effectively with all levels of management, business units (corporate and international), and possesses a high degree of flexibility/selectivity in prioritizing business unit deliverables to meet company goals
Stay current with industry trends, regulatory changes, and best practices in technical writing and medical device documentation
Provide guidance and mentorship to junior technical writers and other team members
Manage fast-moving documentation projects, including timelines, resources, and deliverables
Participate in, conduct, and drive cross-functional team meetings to provide input on documentation requirements and timelines
Qualification
Required
experience in regulated industry (FDA, FCC, DoD, etc)
experience with authoring tools (MadCap Flare, Adobe FrameMaker, InDesign, Illustrator)
experience with end-user documentation (IFUs, customer-facing manuals and guides)
Experience working in a regulated industry such as medical devices or pharmaceuticals
Extensive experience with regulatory compliance processes. Strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines
Demonstrated ability to be highly collaborative with marketing, clinical, quality, and regulatory reviewers
Five or more years writing and editing hardware/software user guides (print and online) and other technical product documentation
Ability to effectively manage the delivery of prioritized tasks
Ability to demonstrate a high level of initiative to gather information for developing documentation
Ability to work independently with minimal supervision
Effective at thinking independently and solving problems with product core team members
Ability to work under compressed deadlines and must be able to deal with unresolved situations, frequent project changes, delays, or other events
Ability to handle multiple projects with excellent follow-up and project management skills
Familiarity with electro-mechanical concepts and software application usage
Experience in device labeling and/or packaging content development
Familiarity with large company engineering change control processes and Agile software development methodologies
Preferred
Experience with SAP, Oracle, or similar enterprise resource planning (ERP) system is a plus
Experience in version control systems (VCS) such as, Perforce, Apache Subversion, Microsoft Team Foundation Server, or GitHub
Knowledge of photography and photo editing software such as Adobe Photoshop
Skilled in both electronic and hard copy markup (Acrobat, tracked changes in Microsoft™ Word™, standard editorial and proofreading symbols)
Knowledge and experience with desktop publishing (DTP) software applications (MadCap Flare, Adobe FrameMaker, Adobe InDesign, Adobe Illustrator, XML, DITA) as applicable for technical documentation
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase