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Documentation Specialist

Website Soligenix, Inc

WHO WE ARE:

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Soligenix has specialized expertise in the development of orphan and unmet medical need indications – including the regulatory nuances and clinical execution associated with small and difficult to treat disease indications. Soligenix directly conducts all of its Phase 2 and 3 clinical studies, being in direct personal contact with the study sites and principal investigators, ensuring the highest data quality while streamlining timelines and budgets. In order to accomplish this, Soligenix has an extremely dedicated, cross-functional team seasoned in the development of rare diseases.

POSITION SUMMARY:

The primary role of the position is to coordinate the critical documentation management systems supporting all development programs for Soligenix. This includes ensuring the accuracy and completeness of critical documentation, and performing routine filing of both paper and electronic files. The individual processes, issues and tracks all documentation supporting development programs including clinical (inclusive of the trial master file), nonclinical and chemistry, manufacturing and controls (CMC) documentation. The role requires maintenance of a Document Control Access database and will facilitate the coordination of document review and revising including, but not limited to, standard operating procedures, specifications, protocols, forms and high-level clinical documents. The individual will also be responsible for issuing and distributing final controlled documents. Secondary, yet essential, roles of the position will included assisting with the compilation of regulatory filing documents, coordination of stability program oversight and product shipping coordination.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Oversee maintenance of Document Control paper and electronic files.
  • Ensures all personnel are distributed the appropriate controlled documentation in a confidential manner.
  • Coordinates review and approval of all critical GxP documentation.
  • Coordinate periodic reviews critical documentation in accordance with SOPs.
  • Oversee off-site document archives (currently stored at an Iron Mountain facility).
  • Create and maintain the trial master files supporting Soligenix clinical studies.
  • Review of all documents undergoing revision to confirm the format and presentation comply with Soligenix standards and SOPs.
  • Assists with the stability programs, including updating data tables and distribution of data to key stakeholders in the programs.
  • Coordinate shipments of bulk drug substance and finished drug product as needed.
  • Support regulatory team in preparation of regulatory filings as needed.
  • Must be able to collaborate effectively and build bridges across sites, organizations and functions.
  • Able to work independently and to execute multiple projects in a timely manner; must be detail oriented and have strong prioritization skills.
  • Able to work effectively on daily tasks with minimal instruction and supervision.
  • Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • BS in a life sciences field preferred but not required.

YEARS OF EXPERIENCE:

  • 1-3 years of experiences in the biopharmaceutical industry preferred by not required.

PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:

N/A

OTHER SKILLS AND ABILITIES:

  • Highly organized and strong eye for detail.
  • Experience and have demonstrated an ability to manage at a high level of productivity with minimal infrastructure.
  • Proficient knowledge of Word, Excel, PowerPoint, and Access.
  • Ability to function well in a cohesive management team environment; strong goals and results oriented.
  • Proven verbal and written communication skills.
  • Demonstrated experience in implementing processes and systems is a strong plus.

How to Apply

Please provide resume, references, and current location via e-mail. Soligenix, Inc. offers a competitive compensation and benefits package. Soligenix, Inc. is an Equal Opportunity Employer. Compensation will be commensurate with experience. No phone calls, please. No recruiters.

To apply for this job email your details to hr@soligenix.com