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CMC Technical Writer (Regulatory)

 
Requisition ID:  2968
Location: 

Bothell, Washington, US

Date:  Jun 24, 2022
 

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!

SUMMARY


Lundbeck Seattle BioPharmaceuticals is seeking an experienced CMC technical writer to lead the authoring, review and approval of various regulatory documents including the CMC sections of regulatory submissions, briefing documents and information request responses to support multiple biologics products in the clinical and commercial stages of development.  This position is within the CMC Biologics area and will require a high level of collaboration with stakeholders including the Regulatory CMC group.

ESSENTIAL FUNCTIONS

  • Serve as primary author and/or provide support 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 Lundbeck style requirements; train authors in CMC functional areas on these requirements
  • Closely interact with the data verification team and SMEs to ensure data integrity review for all relevant documents is completed in accordance with timelines
  • Monitor review process to ensure appropriate tracking and resolution of comments
  • Partner with Regulatory CMC, Project Management and project teams to develop timelines for deliverables; monitor CMC progress against timelines and escalate risks to CMC management
  • Interact with external vendors (such as contract labs or contract manufacturing organizations) as required to support document deliverables
  • Develop, implement and maintain a standardized process for authoring, review, and approval of CMC regulatory documents with input from key stakeholders including Regulatory CMC, QA and CMC Biologics
  • 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 health authority questions, gap assessments or other learnings related to CMC regulatory documentation; refine templates and guidelines based on this knowledge

 
REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Bachelor's of degree or Master's degree with 5+ years’ experience in the biologics, pharmaceutical or medical device industry in a CMC functional area such as Analytical Development, Quality Control, Regulatory Upstream Process Development, Downstream Process Development or Formulations.
  • Demonstrated experience with technical writing within either a regulatory CMC or CMC functional area
  • Strong written communication skills with ability to summarize scientific data in a logical, organized, clear and persuasive manner
  • Demonstrated proficiency with managing project timelines and deliverables across multiple functional areas and projects
  • Strong attention to detail with a focus on ensuring format/style requirements are met (for text, tables, references, hyperlinks)
  • Ability to work cross-functionally with excellent verbal communication and collaboration skills
  • Strong knowledge of computer programs including Word, Excel, PowerPoint and Adobe Acrobat
  • Familiar with the eCTD format and the content of CMC sections of regulatory filings
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation.

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS: 

  • Ph.D. with equivalent combination of education and experience
  • Broad understanding of CMC functional areas including the requirements for development, manufacturing and testing of biologics products
  • Familiar with ICH guidelines
  • Experience with United States and European pharmacopeial requirements and Good Manufacturing Practices; experience in additional global jurisdictions is a plus
  • Previous experience with writing CMC sections of regulatory submissions including Module 3 and Module 2.3, briefing documents, and responses to regulatory information responses
  • Proficiency with using electronic tools (such as Microsoft Teams or Sharepoint) for collaboration
  • Familiarity with the typical “voice” used in regulatory documents; ability to ensure consistency of voice and terminology throughout document

#LI-LM1

 

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

 

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
 

 

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.


 

About Lundbeck

Tirelessly dedicated to restoring brain health, so every person can be their best

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint

Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).  

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global, and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck and via LinkedIn.