Immediate Opening for a CMC Scientist that would like to transition into Technical Writing!
The Contract, Associate Scientist (Technical Writer) - CMC supports the CMC team by collaborating with authors and SMEs to review results/data, protocols, and create documents that include, but may not be limited to, SOPs, laboratory notebooks, analytical raw data, and summary reports. This involves careful review of current documents/data, providing feedback to original authors/scientists, and authoring summary documents. The incumbent is also responsible for applying appropriate document templates, standards, style and terminology across documents.
The incumbent works cross-functionally with internal departments and external resources on GxP-related procedural documents.
The Contract, Associate Scientist - CMC supports adherence to relevant regulatory requirements and company SOPs as appropriate.
location: Lynnfield, Massachusetts
job type: Contract
salary: $30 - 35 per hour
work hours: 9 to 5
- Collaborates with GxP Subject Matter Experts (SMEs) and teams to write, review or edit technical reports/protocols and verify data.
- Performs document data verification.
- Ensures good documentation practices are followed.
- Coordinates with various departments to assure that development document(s) clearly are indicative of the process and understandable to the reader.
- Acts as liaison between CMC, Regulatory Affairs, and Quality Assurance, as well as representatives of third parties, that the document is being written for.
- Performs other related tasks and assignments as needed and specified by management related to development document and data generation or reporting.
- Bachelor's degree in a relevant scientific discipline and a minimum of 2 years of laboratory scientific work or technical/scientific writing in a pharmaceutical, biotechnology, contract research organization or related environment/industry OR equivalent experience and/or education.
- Must have some technical knowledge of laboratory procedures in the Biologics/Gene & Cell Therapy fields (process development, molecular biology, adherent cell culture, chromatography)
- Ability to review, write, and edit development reports and protocols, ensuring that these documents adhere to applicable regulatory FDA, EMA, ICH guidelines and standards.
- Experience in working in a GXP environment.
- Strong technical comprehension.
- Experience with process mapping and project management concepts.
- Excellent attention to detail, including data integrity, logical flow, and formatting.
- Proficiency with Microsoft Office and use of electronic document templates.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Excellent planning, organization and time management skills.
- Broad knowledge of ICH guidelines, FDA CFRs, EMA directives and other regulatory guidelines.
- Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and working to tight timelines.
- Excellent interpersonal skills and attention to detail.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.