What are the responsibilities and job description for the Mgr GRAAS Operations position at Advanced Bio-Logic Solutions Corp?
Description:
Note:
Remote worker - West coast time zone Preferred.
Roles & Responsibilities:
Basic Qualifications:
Top 3 Must Have Skill Sets:
Red Flags:
Pay Rate open rate on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
Note:
Remote worker - West coast time zone Preferred.
- The ideal candidate for this role is an experienced submission management professional with at least four years of hands-on experience in regulatory operations within the pharmaceutical or biotechnology industry.
- They should be a subject matter expert in eCTD publishing and submission assembly, comfortable with Veeva Vault RIM, and knowledgeable about submission content plans and validation publishing.
- Strong planning and timeline negotiation skills are essential, as this person will coordinate with cross-functional teams and manage vendor relationships to ensure timely submissions.
- The candidate should also be detail-oriented, capable of quality-checking vendor-published submissions, and flexible enough to step in for urgent publishing tasks when needed.
- Experience with Docu Bridge or similar publishing tools is a plus. Minimum of 4 years of relevant experience is required.
Roles & Responsibilities:
- Manage various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans
- Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
- Serve as primary point of contact between functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in the appropriate system
- Independently remain current on guidance (internal/external) and translate requirements into operational activities
- Effectively represent global submission management expertise on key projects and global workstreams
- Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
- Contribute to the development of the strategy for communicating with global health authorities
- Represent departmental expertise on global work streams
- Initiate, lead and manage process development and improvement
- Lead information system and software update projects as well as ongoing system validations from a publishing perspective
- Provide technical support for regulatory systems
- Manage relationships with contributing functions and affiliates
Basic Qualifications:
- Doctorate degree
- Master’s degree and 3 years of experience
- Bachelor’s degree and 5 years of experience
- Associate’s degree and 10 years of experience
- High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
- Advanced knowledge of Veeva Vault RIM,
- Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications
- Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans.
Red Flags:
- Have not worked in regulatory, regulatory operations, publishing or submission management roles.
- Lack of directly related submission management experience.
- No pharma or biotech experience (while open to candidates from med device but that cannot be the only experience)
- No experience with eCTD publishing, Veeva Vault RIM, or validation publishing.
Pay Rate open rate on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
