Overview

The Technical Writer is responsible for creating, reviewing, and editing technical documents, including change controls, risk assessments, manuals, specifications, standard operating procedures (SOPs), work instruction (WI’s), label revisions, audits and health authority audit responses and submissions, and scientific papers. The Technical Writer will own and investigate Supply Chain related deviations, working with cross functional stakeholders to perform simple and complex root cause analysis to root cause and identify corrective actions to close assigned deviations on time. The role requires a strong attention to detail, the ability to understand complex scientific and technical concepts, and excellent writing and communication skills.

Specific Responsibilities

• Work closely with cross functional subject matter experts, scientists, engineers, product managers, and quality assurance personnel to gather technical information and create documentation that is accurate, clear, and concise, using specified electronic documentation software work flows as necessary.
• Develop, manage, track and maintain change control documentation related to Supply Chain process revisions and continuous improvement opportunities; ensure that all proposed changes are documented accurately adhering to regulatory and company standards.
• Coordinate and author change requests and comprehensive risk assessments required to support implementing alternate sources of direct and indirect materials, working with cross-functional teams to gather data and create a robust and resilient material change management process.
• Oversee the creation, revision, and approval of GMP compliant labels for all products associated with clinical and commercial products, domestically and globally; ensure all labels meet regulatory requirements, maintain consistency with company standards, and accurately reflect product specifications; collaborate with various departments including Quality Assurance, Regulatory Affairs, Manufacturing and Marketing to ensure timely and accurate label updates and revisions.
• Investigate Supply Chain deviations, working with cross-functional teams to gather data, lead and perform Root Cause Analysis to determine the likely root cause of the event; provide routine updates on investigation status and alignment on findings, proactively communicating roadblocks and challenges in a timely manner that can impact task and timely delivery of investigation.
• Identify Corrective and Preventative actions to prevent recurrence; oversee CAPA submission, tracking, and execution as it pertains to recommended Supply Chain investigation and/or audit resolutions.
• Ensure all documentation is compliant with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards. Create and maintain standards guides for the department, ensuring consistency across all documents.
• Develop and maintain knowledge of biotechnology, stay up to date with the latest developments in biotechnology and maintain a strong understanding of the scientific concepts and terminology used in the industry.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.

• Collaborate in a team environment or work independently as required; work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

• Performs other duties as assigned by leader.

Required Education, Skills, and Knowledge

• Bachelor's degree, with a minimum 3+ years of experience in technical writing, preferably in the biotechnology industry. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed.
• Experience utilizing root causes analysis tools and identifying corrective and preventative actions is required.
• Ability to build relationships quickly and credibly across departments and a variety of personalities and experience levels.
• Ability to work successfully in a fast-paced team-oriented environment, with the ability to also work independently with minimal supervision.
• Must be able deal with ambiguity – ready to change gears and plans quickly, able to manage constant change.
• Proactive, results oriented, self-starter, with the ability to work successfully in a fast-paced team-oriented environment.
• Strong attention to detail and excellent writing skills. Must have strong written and verbal communication and organizational skills. Must be able to read, write and understand English especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook).
• Ability to understand complex scientific and technical concepts and translate them into clear, concise documentation.
• Strong computer skills, problem solving and attention to detail.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
• Ability to stand/sit/walk for long periods of time.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.

Preferred Education, Skills, and Knowledge

• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• Experience with FDA, EMA, and ISO regulations and standards.
• Familiarity with document management systems and version control.
• Prior experience in Supply Chain Environment or troubleshooting Supply Chain related issues preferred.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

Mental:

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

• This position will work in both an office, manufacturing, and Warehouse environment.
• When in the manufacturing or warehouse, must be able to work with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

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