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Technical Writer (Combo Products/Medical Devices)

Kymanox


2 weeks ago

Job type: Contract

Remote (USA Only)

Hiring from: USA Only

Category: Writing


We are looking for a Technical Writer to join our team in a long-term contract position.

Job Description:

The position will be engaged in leading key aspects of Kymanox’s technical writing and supporting clients on a portfolio of two to three projects covering a wide range of engineering, compliance, and commercialization challenges related to combination products.

Projects may include any of the following focus areas:

  • Combination Product Development and Commercialization (all aspects)
  • Design Controls (e.g., expert DHF support)
  • Risk Management
  • Design Inputs
  • Design Verification and Validation (V&V)
  • Human Factors Engineering
  • Process Improvement and Troubleshooting
  • Technology Transfer and Scale-Up
  • Validation (e.g., Shipping, Process)
  • Data Analysis, Including Statistical Analysis
  • Regulatory Submission Authorship and Review
  • Project Management Leadership and/or Support
  • Technical Report Authorship, Review, and Formatting
  • Manufacturing and Complaint Investigations
  • Quality Management Systems (QMS) Support
  • Process and Product Development (including design)

Additional responsibilities can include:

  • Serve as support for single point-of-contact on projects, executing as technical team lead and assisting other resources.
  • Author technically simple and complex documentation to ensure technical competence to relevant local and federal regulations
  • Support the completion of gap assessments against industry regulations or standards
  • Develop policies or standard operating procedures under some level of direction from senior resources and management
  • Others responsibilities as applicable

Educational Background:

  • Bachelor’s degree in any Engineering discipline (prefer Biomedical, Mechanical, or Chemical engineering) from an accredited institution or equivalent. 

Experience:

  • 1-3 years of experience in development and/or manufacturing, in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
  • Experience in Technical Writing within the Pharma, Medical Device or BioTech industries is desired.

Desired Aptitude and Skill Set:

  • Resourceful
  • Extremely detail oriented
  • Ability to work effectively with remote team members
  • Highly organized
  • Self-directing, self-pacing
  • Excellent written and oral English communication skills
  • Understanding of own limitations
  • Ability to solicit and utilize subject matter expert input
  • Fast learner
  • Pleasant and positive communication style
  • Strong customer-service aptitude
  • Ability to motivate self, team members, and direct reports
  • High energy level
  • Excellent problem-solving skills
  • Seasoned soft skills (i.e., high EQ)
  • Team player
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Technology savvy

About Kymanox:

Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.

Kymanox is looking for motivated individuals ready to continue a career in the life sciences and at a higher trajectory. Kymanox provides professional services related to engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-up companies to government agencies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and New Jersey.

Before you apply, please check if any restrictions apply in terms of time zone or country.

This job has a geo-restriction in place: USA Only.

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