LanceSoft
Medical Writer
This job is now closed
Job Description
- Req#: 25-250392
- Provide medical writing directions and guidance aligned with the company’s style guide for assigned projects, including the review of work products.
- Convert relevant data and information into formats that comply with TM document requirements and coordinate the review of the final products.
- Understand, assimilate, and interpret various sources of information with appropriate guidance and direction from the TM team.
- Confirm the completeness and accuracy of information presented in documents.
- Perform literature searches as needed to gather relevant content for drafting documents.
- Maintain expert knowledge of US and international regulations, requirements, and guidance associated with scientific publications, including US FDA and ICH guidelines.
- Utilize prior knowledge of preclinical strategy, pharmacology, toxicology, and GLP practices to ensure that documents drafted at the Company are prepared for regulatory inspection or audit in the US or Europe.
- Complete draft reports based on data provided by Company’s Subject Matter Experts (SMEs) to ensure thoroughness and compliance.
- Review draft training modules on GLP’s, regulatory writing and FDA interactions and provide suggestions on ways to modernize.
- Advanced degree in Life Sciences, Pharmacy, or a related field.
- Proven experience in medical writing within the pharmaceutical or biotech industry.
- Regulatory Affairs Certification and/or PMP certification
- Strong understanding of regulatory requirements and guidance related to scientific publications.
- Excellent analytical skills and attention to detail.
- Ability to work collaboratively with cross-functional teams and communicate effectively.
- Proficient in conducting literature searches and synthesizing information.
- Excellent knowledge of English language
- Attention to detail
As a Medical Writer, you will play a crucial role in providing medical writing direction and guidance for various projects. Your expertise will ensure that all documentation aligns with the Company’s style guide and meets the necessary regulatory standards (US and EMA). You will be responsible for the following:
Key Responsibilities:About the company
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.
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