Job Description

A highly reputable pharmaceutical corporation is currently hiring for a Remote GMP Technical Writer (West Coast based) to work in San Francisco, CA.

JOB DESCRIPTION:

• In preparation for licensure and pre-approval inspection readiness, Technical Writer to develop Quality Standards and related SOPs that may include, but not be limited to:
• Manufacturing and GMPs
• Facilities, Utilities and Equipment
• QC Laboratory Controls
• Specifications
• Clinical Operations and GCPs
• Additional documents may be included in scope at client’s request.

RESPONSIBILITIES:

• Develop in partnership with the company Subject Matter Expert, new procedures and/or review/revise existing procedures to meet regulatory agency compliance standards and internal operational requirements.
• Apply technical knowledge and clinical quality expertise when developing the documents.
• Partner with client on content and to finalize documents. Ensure all procedures are:
• Perform technical writing on all procedures:
• Follow-up with reviewers and stakeholders to ensure documents meet project timelines.
• Partner with client team members to identify issues, formulate recommendations, and execute solutions, as applicable.
• Document gaps, risks, and likelihood of occurrence; facilitate risk mitigation activities.
• Ensure accepted risks and risks with long-term remediation horizons are clearly documented, justified, and decision makers noted.
• Lead and facilitate document review meetings.
• Focus on reconciling feedback and adjourning with approvable documents.
• Manage document approval process.
• Develop, manage, and routinely publish a project status report that:
• Provide a list of parking lot and open items (if any) at time of hand-off.
• Accommodate teleconferences with individuals in other geographies as required

EXPERIENCE:

• Bachelor's Degree
• 2+ years highly relevant experience in an industry setting
• 2+ year of technical or scientific writing experience
• Technical Writer based on the west coast strongly preferred
• Experienced in a cGMP environment
• Must have demonstrated expertise in authoring SOPs or similar process directed documentation
• Strong Computer skills required

KEY ATTRIBUTES:

• Self Starter
• Driven to perform
• Self-directed: needs little explicit direction and a motivated and independent worker
• Able to organize and prioritize a diverse set of responsibilities to ensure that focus on the success of the company is achieved
• Strong writing and communication skills
• Strong science acumen
• Ability to multitask and work within a fast-paced dynamic team environment.
• Strong interpersonal, team working, and leadership skills.

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.