Life Sciences Clinical Document Specialist
3 weeks ago
Job Overview:
We are seeking a skilled Clinical Document Specialist to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma, and IT.
The ideal candidate will have advanced documentation preparation and project management skills, with experience in developing, drafting, reviewing, editing, and finalizing documents for clinical studies and regulatory submissions.
This is a contract position offering $53 per hour, paid via W2 only. No STEM OPT candidates are considered.
Responsibilities:
- Draft and edit documents used for submissions, including CTDs and RtQs
- Draft and edit documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
- Draft and edit documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PSURs, DSURs, etc.)
- Manage study team participation in document preparation, including calling meetings, developing timelines, and managing review and comment adjudication processes
Requirements:
- At least 5 years of experience in medical writing or scientific writing
- Familiarity with the drug development process, clinical study protocol design, and study conduct
- Experience writing, reviewing, or editing protocols and clinical study reports highly preferred
- Intermediate to advanced knowledge of AMA, CBE, and Chicago Style Manuals
- Ability to interpret basic tabular and graphical clinical data presentations
Skills and Qualifications:
- Proficient in Microsoft Word, Excel, and PowerPoint
- Experienced with scanners, printers, and copiers
- Basic knowledge of regulatory requirements and guidance associated with standalone regulatory documents
- Effective communication and conflict management skills
About Lifelancer:
Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
If you're looking for a challenging and rewarding role, please apply on the Lifelancer platform.
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