Documentation Specialist – Contracts and Archiving (Supervisor)

Location
South San Francisco, CA, United States
Posted
May 29, 2021
Ref
5233976002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

The Documentation Specialist - Contracts and Archiving (Supervisor) is responsible for the archiving and retrieval of all data (including e-data) generated from the conduct of non-clinical studies in accordance with Good Laboratory Practice (GLP) regulations and governing Standard Operating Procedures (SOPs). The Documentation Specialist will maintain an index/catalog to ensure that study records can be found in orderly and expedited retrieval manner that supports a Quality environment. Additionally, this person will manage, negotiate, and execute contracts supporting nonclinical outsourced activities, working as liaison between vendors and project team representatives. Must have strong communication skills and the ability to have oversight on several multifaceted studies at once that are either conducted in-house or at a CRO.

DUTIES AND RESPONSIBILITIES
  • Ensure each current study record is checked and filed and is inspection ready - meets requirements for 21 CFR Part 58 and where applicable 21 CFR Part 11 as well as FDA requirements for maintenance of study records for IND-enabling non-clinical studies
  • Conform to Standard Operating Procedures (SOPs) and Good Laboratory Practice Regulations (GLP) in the US, EU, and regional specific requirements
  • Establish effective communications with Study Directors, Study Monitors, Quality Assurance, and other key study personnel
  • Assist study team to resolve errors and other items of noncompliance, track timeliness of documents to be filed within the electronic document file system
  • Ensure that all electronic and paper raw data, documentation, protocols (including amendments/deviations), final reports and samples collected from the study are retained in accordance with the approved protocol and GLP regulations
  • Ensure that test and control articles used on non-clinical studies are retrieved and work with CMC for appropriate inventory and retention in accordance with the approved protocol and GLPs
  • Maintain archival of tissue samples as needed for long-term retention to designated offsite archive for Pathology
  • Organize and file study and facility documents; ensure that materials retained in the archive are appropriately indexed to permit expedient retrieval
  • Maintain the company Master Archive index per retention policies and regulation
  • Update and generate new SOPs or Guidelines as assigned
  • Participate in QA audits as needed
  • Drive the execution of legal contracts - CDA/NDA, MSA, SOW and POs as needed by Pharmacology and Toxicology investigators
  • Contract life-cycle oversight - Review, process and day-to-day management of a variety of contracts with select vendors
  • Provide contract support for reliable execution of outsourced activities
  • Liaise with study teams, Legal and Finance functional groups for contract maintenance and tracking
  • Provide Associate Director of Nonclinical Operations with regular updates on work performed

QUALIFICATIONS

Basic Qualifications
  • Bachelors in a scientific discipline plus 4-6 years or equivalent combination of education and work experience preferably in a pharmaceutical industry
  • Understands basic in vivo study design principles and has worked in either a Quality or GLP regulated environment
  • Must be detail oriented, with ability to multi-task and work cross-functionally with team members and team environments
  • Effective communicator both verbally and in writing
  • Excellent interpersonal, organizational and problem-solving skills required to manage multiple tasks at different phases in parallel and track work and projects to meet timeline demands
  • Proficiency with MS Office (Word, Excel, PowerPoint etc) and a database system for storing and tracking documents or study samples
  • Works on problems of diverse scope and demonstrates good judgment in problem-solving
  • Ability to handle several fast-paced projects concurrently
  • Ability to collaborate and be a strong team player
  • Demonstrate curiosity and scientific rigor
  • Ability to engage in crucial conversations - providing and receiving feedback
  • Working safely in person on a predictable and regular in-person basis is an essential job function for this position and the Company requires that all individuals working in-person, subject to certain exceptions, be fully vaccinated against COVID-19.

Preferred Qualifications
  • Bachelors and or Masters degree plus 4-6 years, or RQAP credential in GLPs, or training in Quality Management Systems (QMS)
  • Familiarity with GDP, GLP regulations (CFRs, ICH), laboratory documentation, electronic laboratory notebook (ELN), and/or electronic document management system (EDMS)
  • Familiarity with 21 CFR Part 11 compliance needs for electronic documentation, storage, and retrieval
  • Familiarity working with contracts and or legal to put study agreements in place or similar translatable skills
  • Strong computer software skills desired and ability to work with and communicate with IT colleagues


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The job description listed above is representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

The Company is committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. We cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short and long term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.