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CMC Technical Writing Lead

Date: Jul 2, 2022

Location: Philadelphia, PA, US, 19104

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

The CMC Technical Writing Lead will work closely and coordinate Technical Development and Operations (TD&O) subject matter experts, interdisciplinary CMC teams and interface with the CMC Regulatory organization to develop templates and draft complex technical documents for rAAV gene therapies.  This includes procedures, protocols, input to regulatory submissions, responses, information requests, briefing documents & clinical trial applications

She/he will operate in a highly interdisciplinary environment and be expected to communicate effectively and productively with research, development, operations, regulatory, quality, and other departments as needed to ensure that rigorous scientific, technical, and product quality expectations are achieved.

 

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

70%

The primary responsibilities of the CMC Technical Writer are to:

  • Serve as the primary author and/or point of coordination to authors within CMC functional areas for writing and/or revision of regulatory CMC submissions (Module 2.3 and Module 3), briefing documents, responses to information requests and other CMC technical reports as required.
  • Ensure documents comply with eCTD and internal Spark quality requirements
  • Closely interact with CMC subject matter experts to conduct data verification and ensure data integrity review for all relevant documents are completed in accordance with timelines
  • Monitor review process to ensure appropriate tracking and resolution of comments
  • Partner with Regulatory CMC, CMC Program Management and CMC teams to develop timelines for deliverables; monitor CMC progress against timelines and escalate risks to TD&O management
  • Interact with external vendors (such as contract labs or contract manufacturing organizations) as required to support document deliverables
  • Develop and maintain templates and or other guidelines to ensure consistency of information in regulatory submissions and a phase appropriate approach
  • Develop and maintain a process for knowledge sharing across programs based on process learnings, health authority questions, gap assessments or other learnings related to CMC technical documentation; refine templates and guidelines based on this knowledge

20%

  • Coordinate with TD&O full time and contracted technical writers to ensure consistency of documentation practices (e.g. formatting, continuity of technical information/data), navigation and storage of documents in Spark systems, harmonization of templates

10%

  • Training, meetings, and other administrative work

 

 Requirements

  • Ph.D. in a relevant scientific or engineering discipline with 5+ years of applicable experience or Bachelors/Masters in a relevant scientific or engineering discipline with 9+ years of applicable experience.
  • In-depth CMC experience in analytical, process or formulation development for gene therapy, biologics, or vaccines is required
  • 3+ years being a part of CMC development teams preferred
  • Has previously authored technical reports, regulatory submissions, and/or responses to regulatory requests

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location.  Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia