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Technical Writer V in Cambridge, MA at Integrated Resources, Inc

Date Posted: 1/2/2019

Job Snapshot

Job Description

TBOS Local
1 year contract to start

OBJECTIVES:
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.

ACCOUNTABILITIES:
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

Regulated Responsibilities
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

LICENSES/CERTIFICATIONS:


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.