Sr. Technical Writer is needed to create and update policies, standard operating procedures (SOPs), job aids and other types of controlled documents for all functions within R&D.
location: Cambridge, Massachusetts
job type: Contract
salary: $40 - 65 per hour
work hours: 9am to 5pm
ESSENTIAL JOB FUNCTIONS - Prepare and review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures. - Support Process Owners in the development and streamlining of content, including processing mapping and RACI tables. - Work with subject matter experts and key functional department personnel to ensure timely development and accurate content of required documentation. Recommend revisions or changes in scope, formatting, and content as identified. - Perform Quality Control reviews on process document content and formatting. - Maintain and coordinate activities related to the document creation using the EDMS including document initiation, workflow support, revision, and retirement. - Monitor shared mailboxes for documentation related requests; engage wider team for support in responding to non-documentation requests, as required.
QUALIFICATIONS Education B.A. or B.S. degree or equivalent required Experience
- Minimum of five (5) years of experience writing controlled documentation in the biotechnology or pharmaceutical industry
- Direct experience in GXP-compliant quality systems is preferred
- Knowledgeable in FDA regulations
- Experienced in Microsoft office applications specifically Word, Excel and Visio Skills - Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes;
- Excellent communication skills including: technical writing, interpersonal and collaborative skills;
- Excellent organization skills with the ability to stay accountable to deliverables and milestones;
- Ability to thrive and multi-task in a steady-paced environment;
- Must have in-depth knowledge and understanding GXP regulations, and controlled document management principles;
- Must work effectively in a team environment and with individuals at all levels within an organization.
skills: Write technical materials, such as equipment manuals, appendices, or operating and maintenance instructions. Collects and interprets technical data or information and coordinates layout for publication. Requires a bachelor's degree and 5-7 years of related experience.
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.