Primary objective of this role will be to deliver comprehensive and high quality clinical and preclinical technical documents supporting Soligenix biotherapeutics and biodefense development programs. This will include documentation supporting regulatory applications in the US as well as ex-US in compliance with appropriate standards (e.g., International Council on Harmonization, ICH) as well as publications, abstracts and presentations.
Essential Duties And Responsibilities
- Write and compile clinical documentation necessary for investigational new drug (IND) applications, new drug applications (NDAs), biologic license applications (BLAs), and device applications (510(k) and PMA) in the US and the equivalent documents ex-US.
- Drafting of and annual updates to clinical Investigator’s Brochure.
- Drafting of clinical protocols and associated amendments and corresponding change documents.
- Drafting of clinical study reports and final assembly.
- Writing manufacturing, pre-clinical and clinical summaries and overviews in the common technical document format.
- Drafting of protocols and study reports for nonclinical studies (e.g., model development studies).
- Review and approval of critical technical documents provided by Contract Research Organizations (CROs).
- Must be able to collaborate effectively and build bridges across departments 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.
EDUCATIONAL REQUIREMENTS (degree, License, Certification)
- Bachelor degree in a life sciences field, MSc/PhD preferred
Years Of Experience
- Minimum of 3 years technical writing experience, with 2-5 years experience in the biopharmaceutical industry.
- Participation in the finalization of more than 2 clinical study reports in compliance with ICH standards.
- Authored multiple technical publications/abstracts.
- Participation in the finalization of more than 2 nonclinical study reports supporting regulatory submission in the US.
- Experience in data review include simple statistics, data graphing, and ability to summarize findings
- Requires an in-depth familiarity with ICH requirements.
PHYSICAL REQUIREMENTS/WORKING CONDITIONS Of POSITION
Other Skills And Abilities
- Motivated team player who wants to make a real difference and thrive to exceed expectations.
- Experience and have demonstrated an ability to manage multiple tasks at a high level of productivity with minimal infrastructure.
- Proficient knowledge of Word, Excel, and PowerPoint.
- Ability to work efficiently in a matrix environment with multiple collaborators within and outside of the company.
- Proven verbal and written communication skills.
- Demonstrated experience in implementing processes and systems is a strong plus.
Candidates will be asked to supply examples of previous writing and be willing to create a short example on a supplied topic.
Soligenix, Inc. 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 two areas of focus: 1) a therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as cutaneous T-cell lymphoma, oral mucositis, pediatric Crohn’s disease, acute radiation enteritis, and 2) a vaccines/biodefense segment to develop vaccines and therapeutics for military and civilian applications in the areas of ricin exposure, gastrointestinal acute radiation syndrome, and melioidosis.
Posted 1w ago
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