My name is Bhawna and I'm a Technical Recruiter with ACS Group, a leading information technology services and workforce solutions company.
We currently have an opportunity for a "Technical Writing Manager" with one of our clients in the "Lawrence, NJ" area.
Job Title: Technical Writing Manager
Job Location: Lawrence, NJ
Duration: 12+ Months W2 Contracts
Quality Standards and Learning Management (QS&LM) is a sub-group of the Global Quality Functional group called Global Quality Systems. QS&LM consists of quality professionals that have the primary responsibility for Global Quality learning management and managing selected policies and procedures in R&D and GPS.
Manage or people while create and/or revise procedural documents in R&D and GPS. Procedural management activities include, but are not limited to, working with subject-matter experts to ensure accurate document content and compliance with health authority regulations and expectations.
- Synthesize feedback from subject matter experts/ PD teams to identify and resolve issues in order to accurately document current and future PDs
- Effectively manage projects, escalate issues as necessary and identify/meet key milestones
- Collaborate with appropriate Regulatory colleagues on changes to new or revised GXP/ICH Guidelines to manage the interpretation, communication, and implementation of applicable changes to clinical research
- Work with limited guidance to manage the development of PDs for key procedures, seeks input as needed.
- Lead and implement change initiatives to achieve continuous improvement in QS&LM processes, including how PDs are managed, updated, and drives change in the organization
- Identify and lead improvement efforts within the QS&LM group
- Exercise sound judgment, using a risk-based approach, to ensure compliance with PD regulations, practices, and policies.
- Identify and implement state-of-the-art business models and systems for PD management and continuous improvement
- Interpret regulations or contact appropriate resources regarding regulations and maintain an awareness of compliance issues
- Work closely with upper management to identify and work with key stakeholders to ensure that PDs are developed in accordance with current practice and functional needs
- Prepare presentations and other materials to effectively represent the QS&LM department
- Negotiate complex situations without direct authority
Desired Qualifications and Experience
Preferred: PhD with 6-8 years' experience working in a pharmaceutical or highly regulated environment, Master's degree with 8-10 years' experience or Bachelor's degree with 10-12 years' experience.
- Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
- Demonstrated ability to drive organizational change while balancing priorities utilizing strong organizational skills
- Exemplary leadership skills as demonstrated by the ability to manage individuals and teams towards meeting goals
- Ability to drive consensus, drive performance and to lead strategically.
- Demonstrated success in managing project, team effectiveness, facilitation and presentation skills
- Demonstrated knowledge of FDA regulations and ICH guidelines applicable to GXP. FDA regulations and ICH guidelines include, but are not limited to, the following:
- 21 CRF Parts 11, 58, 111, 210, 211, 610 and 820
- ICH Q7, Q8, Q9, and Q10
- High level of competency in PD writing including the appropriate use of grammar, syntax and organization of ideas
- Knowledge of project management concepts and strategies
- Knowledge of requirements for development, use and maintenance of controlled procedural documents
- Demonstrated ability to resolve complex issues and differences in a creative, constructive and diplomatic manner
- Demonstrated ability to work independently and mentor team members
- Demonstrated ability to maintain a high level of productivity, accountability and energy
- Proven teambuilding skills and an ability to foster partnerships across projects and multidisciplinar teams
- Demonstrated ability to follow up on open issues and drive results to completion
- Demonstrated ability to effectively and decisively establish appropriate priorities for self and matrix teams
- Proven track record for taking on challenges that are outside of normal book of work
- Strong communication skills
- Employee Events
- Life Insurance
- Long Term Disability
- Medical, Dental and Vision
- Paid sick days