Job Description:
Purpose:
- Supports accurate and timely completion/delivery of information and review of regulatory submissions while building medical writing knowledge.
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Responsibilities:
- Assists in activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated regulatory documents (US and ex-US). Serves as medical writing support to other writers.
- Learning US and international regulations, requirements and guidance associated with document. Seeks to understand information from a variety of sources with the goal of supporting the conversion of relevant data and information into a form that meets regulatory document requirements.
- Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams and Medical Writing mentor/management. Learns, understands, and complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs. Supports review meetings with the team.
Qualifications:
- Bachelor degree in English or Communications with relevant science expertise or Bachelor degree in Life Science with relevant writing expertise.
- May have 0-1 years industry experience in medical writing or in a related area such quality, regulatory, clinical research, or product support. Demonstrated ability through previous employment or academics to assimilate and interpret scientific content and translate information for appropriate audiences.
- Developing knowledge of US and international regulations, requirements and guidance associated with document preparation and submissions. Developing knowledge with Common Technical Document content templates. Developing knowledge of current electronic document management systems and information technology.
- Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
- Tellus Solutions is in partnership with a committed biopharmaceutical company in Waco focused on providing innovative therapies. Your technical expertise as a Lab Tech II in the area of either Quality Control/Quality Assurance functions will contribute to our client's innovative therapies which will impact the quality and duration of life. Experience in working with collaborative, cross-functional teams. Basic Functioning working knowledge of software programs in Windows environment.
Job Types: Full-time, Contract
Pay: Up to $35.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- Medical Writer: 1 year (Preferred)
Work Location: Remote
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