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Senior Quality Control Specialist/Medical Editor, Medical Writing Operations

Deciphera Pharmaceuticals

Apply before: May 10, 2024
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  • Date posted
    March 11, 2024
  • Location
    Hybrid
  • Apply before
    May 10, 2024
  • Career Level
    Mid-Level

Job Description

Job Description

What’s In It for You:

This is an exciting opportunity for a person with passion and talent. The company believes that medical writing is a science constantly evolving in light of new regulations and technologies. The role provides the ability to work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees.

The Role:

The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Senior Quality Control (QC) Specialist/Medical Editor, Medical Writing Operations. The individual will be the lead QC reviewer across programs/submissions that are part of the growing clinical pipeline.

In this role, the Senior QC Specialist/Medical Editor will perform QC reviews of key regulatory and clinical study documents including, but not limited to, clinical study protocols, Investigator’s brochures, and clinical study reports. This person will contribute to important submissions for some of our lead assets.

This position will report to the Associate Director, Medical Writing Operations in the Waltham, MA office.

What You’ll Do:

  • QC review of regulatory and clinical study documents, including (but not limited to) study reports, IBs, and protocols
  • Uses the electronic data management system (eDMS) to track, route, file, maintain, and archive MW documentation, including clinical study report appendices
  • Acts as a resource for Microsoft Word
  • Regularly interacts with a variety of employees internally
  • Performs high-level information searches in the eDMS and various document repositories; reviews, analyzes, and recommends or takes action based on data captured
  • Ensures compliance with department, company, and industry regulatory requirements
  • Provides troubleshooting and training to all levels on key MW processes and systems
  • Communicates ideas for new processes and/or business operations for process improvement
  • Leads implementation efforts to change internal procedures and processes as assigned
  • Represents MW department on assigned projects and/or task teams
  • May participate or supervise in the development and implementation of MW strategy for specific business processes and MW initiatives, including work on SOPs, work instructions, templates, style guides, and checklists
  • May support MW on programs and cross-functional initiatives
  • Performs other duties as assigned, which may include occasional document writing support

Qualifications

  • B.S. and 4+ years of relevant work experience
  • Proficiency in Microsoft Office applications (including Word, PowerPoint, and Excel)
  • Attention to detail related to consistency, grammar, syntax, and scientific accuracy
  • Aptitude for systems applications, including eDMS, PleaseReview, PerfectIt, and EndNote
  • Knowledge of the AMA Manual of Style, Good Clinical Practice (GCP), and the drug development process
  • Demonstrated knowledge of regulatory guidelines about clinical documentation
  • Aptitude for and interest in scientific concepts in the biotech/pharmaceutical industries
  • Self motivated, solves problems, and adapts to new work requests with minimal instruction and guidance, with the ability to prioritize and manage multiple projects; adapts to changing priorities
  • Excellent interpersonal, verbal, and writing skills
  • Exercises discretion and discernment to handle routine and unusual situations
  • Consistently displays a high level of business insight when completing
  • assignments and projects
  • Able to provide some leadership on a cross-functional team and work effectively in a matrix environment

Additional Information

What Deciphera will Bring:

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following:

  • Non-accrual paid time off
  • Summer vacation bonus
  • Global, company-wide summer and winter shutdowns
  • An annual lifestyle allowance
  • Monthly cell phone stipend
  • Internal rewards and recognition program
  • Munch and learns
  • Medical, Dental, and Vision Insurance
  • 401(k) retirement plan
  • Life and Supplemental life insurance for family
  • ESPP offering
  • Health savings account
  • Flexible spending account for either health care and/or dependent care.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.