Website Soligenix, Inc.
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. Support of business development activities including acquisitions and partnerships.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Write and compile 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.
- 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 revise critical technical documents provided by Contract Research Organizations (CROs).
- Scientific evaluation of external programs with respect to feasibility, cost, and timelines.
- Coordination of technical activities funded by government grants and contracts.
- 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):
- PhD in biological sciences preferred
YEARS OF EXPERIENCE:
- Minimum of 3 years technical experience, with 2-5 years’ experience in the biopharmaceutical industry.
- Authored multiple technical publications/abstracts.
- Experience in data review, including simple statistics, data graphing, and ability to summarize findings
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.
- Highly organized and detail oriented.
- 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.
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.
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