Technical Writer in Richmond, VA at APEX Systems

Date Posted: 2/12/2020

Job Snapshot

Job Description

Job #:  1033465


Apex Systems is looking for a Technical Writer in the Richmond, VA area!



•For immediate consideration, please email your updated resume to Lillie Johnson at ljohnson@apexsystems.com with 'Tech Writer - RVA' in the subject line



Summary/Objectives
The Technical Writer is responsible for writing CMC (chemistry manufacturing control) sections, technical summaries, and related submission components intended for filing with international health authorities (FDA), as well to support numerous other document-development projects like client protocols, reports, SOPs, and various GMP documentation. As a member of the regulatory submission groupworks collaboratively with other team members, clients, and contract research organizations (CRO) to complete writing projects of various scopes, sizes, and durations.
 
Essential Functions
  • Distills technical information from multiple sources into concise and well-crafted written deliverables that are aligned with our highest standards of quality and meet both client and health authority expectations.
  • Using source documentation provided from internal sources, the client and contracted CRO’s, write sections of regulatory documents including Tobacco Product Master Files (TPMF) and Pre-Market Tobacco Product Authorization (PMTA) applications and other related submissions
  • Independently read and digest technical documentation pertaining to the development, manufacture, and testing of various and complex products, asking appropriate questions and conducting independent research as needed to enable the writing of summary sections for regulatory submission
  • Mine through technical documents for relevant data, synthesize information, develop narratives, and construct flow diagrams, tables, and figures as needed to convey technical information
  • Organize the flow of information through documents and write clear and concise technical content using well-constructed sentence and paragraph structure
  • Keep abreast of pertinent health authority guidance, regulations, and trends
  • With guidance from regulatory team members, clients, CRO’s, utilize prior experience and knowledge of GMP and regulatory requirements to ensure that the content and level of detail is fit for purpose and appropriate for that product’s development stage
  • Ensure high quality deliverables are generated at appropriate stages and under agreed-upon timelines
  • Review and provide feedback on the work of colleagues; contribute your technical expertise to the team and be open to learning/cross-training in other technical areas; lead and develop other team members as needed
  • Reviews/approves batch records, change controls, complaints and investigations to ensure compliance with cGMP’s, ICH guidelines and other regulatory requirements
  • Develops/Authors SOPs
  • Supports submittal of regulatory filings and responses to agency inquires
  • Facilitates Interdepartmental and Intradepartmental collaboration to meet regulatory timelines
  • Reviews specifications for starting materials and final product
  • Other duties as assigned

 
Knowledge/Skills/Abilities
  • Education and/or Experience
    • 5+ years experience in one or more of the following subjects: chemistry, biology, behavior sciences, manufacturing, analytical sciences, regulatory CMC writing
    • BS degree or higher in engineering or science
    • Experience contributing to/authoring regulatory submission components and GMP/technical documents
    • Working knowledge of the quality concepts used in the GMP production and development of FDA regulated products
    • Comfortable working remote and in virtual, on-line environments such as meeting rooms (audio/video), file shares, and collaboration spaces
    • Professionalism and self-motivation to work independently and reliably deliver on assignments
    • Demonstrated history of positively and diplomatically working with difficult and challenging clients
    • Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
  • Supervisory Responsibilities – None, although management of projects includes directing project related activities of the project team members.
  • Reasoning Ability – Ability to deal with problems involving several concrete variables in standardized situations.
  • Computer Skills – Excellent writing skills and proficiency with Word; comfort with other standard programs in the Microsoft Office suite of products and with Adobe, proficient with various technologies and software commonly used in the industry. Adequate computer skills for troubleshooting basic and common IT issues to minimize downtime
  • Written Communication – Excellent attention to detail requires. Writes clearly and informatively. Presents numerical data effectively; Able to read and interpret written information.
  • Oral Communication – Superb overall communication skills, ability to speak in positive manner, listens and gets clarification; Responds well to questions; Participates in meetings.
  • Project Management – Organized, methodical, effectively manages time and prioritizes workload. Manages multiple tasks without close supervision to meet deadlines.


Personal Attributes

  • Problem Solving & Critical Thinking– Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully in a manner that does not just solve the immediate problem but views it in relation to a bigger picture; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
  • Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities to remain current with technology utilized; Strives to continuously build knowledge and skills; Shares expertise with others.
  • Interpersonal – Focuses on solving conflict, not blaming; Listens to others without interrupting. Keeps emotions under control; Remains open to others' ideas and tries new things.
  • Team Work – Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests. Supports everyone's efforts to succeed; Recognizes accomplishments of other team members.
  • Organizational Support – Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization’s goals and values; Supports affirmative action and respects diversity.
  • Attendance/Punctuality – Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
  • Dependability – Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
  • Initiative – Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
  • Innovation – Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others’ attention.
  • Motivation – Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
  • Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
  • Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Quantity – Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
  • Must be eligible to work in the United States


 


 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.