- Expiry Date: 18 September 2021
Key Responsibilities and Major Duties
The technical writer positions are responsible to prepare technical documents for global use within Operational Controls including: Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution, and Governance Controls: Management Responsibilities, Training & Qualification, Event Management, Document & Change Management, Quality Risk Management.
Technical Writers skills/competence, experience/knowledge, and Responsibilities:
Excellent technical writing skills.
Expert in MS Office and Collaboration applications.
Experience with electronic documentation management systems (preferable, not required)
Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
Strong verbal and written communication skills
Project management concepts, strategies and skills
Proven ability to understand complex processes/problems and propose alternate solutions to implement global procedures
In depth knowledge of cGxP requirements (includes GMP, GDP, GCP, GLP, GVP) and global health authority regulations with ability to interpret, apply and implement.
Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
Strong negotiating and influencing skills in a matrixed organization.
Ability to drive consensus, performance and to lead strategically
High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas
Ability to participate on teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner
Demonstrated ability to work independently
Includes, but not limited to, document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
Perform compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations.
Support Global Product Development & Supply organization for client electronic document management system.
Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes
Proactively use judgment to manage risk and uncertainty, and to anticipate the need for and implement contingency plans
Effectively participate on projects, escalate issues as necessary and identify/meet key milestones
Work with limited guidance to manage the development of global procedural documents and, seek input as needed
Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies
Ability to identify, manage, and/or escalate issues and risks to timelines
Collects and shares best practices through direct communications and communities of practice
Minimum of a Bachelors degree
5+ years experience in the Biopharm/Pharmaceutical industry
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.