Kelly Services Technical Writer in Cambridge, Massachusetts
Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Technical Writer at a prestigious Fortune 500® company working in Cambridge, MA.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.
Job Title: Technical Writer
Pay: $56.66 per hour
Supports Drug Product Development Department in regulatory filing section authoring for vaccine drug product formulation and process development as well as drug product manufacturing. May also review sections and perform data verification to source information.
Primary responsibilities include:
• Author and review of drug product formulation development, process qualification and production filing documentations including IND/IMPD and briefing books.
• Preparation and review of technical and summary reports to support regulatory submissions. Collaborate cross functionally with SMEs, Regulatory and Quality
• Report document life cycle coordination and/or preparation.
• Regulatory submission coordination
• General quality compliance.
Education, Experience, Knowledge and Skills :
• B.S. with at least 10 years or M.S. with at least 6 years of experience in bio- pharmaceutical manufacturing (vaccine manufacturing experience strongly preferred).
• Extensive experience with drafting regulatory sections for BLA/MAA, IND/IMPD filings and briefing books
• Strong technical writing skills with significant understanding on biologic or vaccine drug product manufacturing processes
• Experience with audit inspections and the preparation of responses to regulatory submission questions from agencies
• Able to manage conflicting priorities and adhere to tight timelines.
• Proven ability to work with a high level of integrity, accuracy, and attention to detail.
• Strong knowledge of word processing applications, database structure, multiple computer applications: electronic document management systems (Documentum or similar applications), EndNote, Oracle, SharePoint.
• Ability to work on several documents at the same time, high attention to detail and accuracy, ability to consistently hit deadlines, excellent written and oral communication skills.
• High level of competency required in teamwork for departmental and cross-functional project teams.
• Fundamental knowledge of worldwide regulatory submissions guidance’s a plus.
• Licenses/ Certifications l N/A
• Physical Demands l N/A
Physical Demands :
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
• Typical office and laboratory bending, stooping, lifting requirements apply.
• Lifting and moving supplies and equipment (up to 50 pounds).
Travel Requirements :
• Limited number of travel may be required.
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com .
Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.