Associate Expert Drug Supply (Technical Writer)

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The Associate Expert Drug Supply will actively manage documents throughout the document lifecycle. He/She/They will own deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing department, and own and drive change controls from initiation to closure.

Your responsibilities will include, but are not limited to:

Technical Writer Coordinator:
• Creation and revision of GMP documentation including Production Batch Records, Standard Operating Procedures, and other documents in all different documentation systems used at Novartis.
• Coordination of timelines, document revisions and review cycles for all GMP documents including delegation to the appropriate groups for review to ensure site readiness for all processes.
• Coordinates the activities of other Technical Writers to deliver on the overall plan, including but not limited to periodic revisions of documents
• Driving the continual improvement of GMP Batch Records and SOPs between review cycle by soliciting and incorporating feedback from Analytical & Process Science, Engineering, and Quality groups.
• Coordinates the activities for documentation preparation with all stakeholders.
• Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Novartis Policies.

Deviation and Investigation Management:
• Author investigations reports and support resolution of product complaints, Out Of Expectation, Out Of Specification, Out of Tolerance results. Use process knowledge and root cause investigation tools to identify root causes of product and process deviations. Work cross-functionally to assess and analyze deviations and investigations to determine impact
• Ensures robustness (complete, accurate and defendable) of all critical and major investigations

Change Controls:
• Owns, manages and drives change requests with high complexity to ensure that the changes are implemented on time.
• Develop robust implementation plans based on impact assessments performed by the SMEs.

Training:
• Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you'll bring to the role:

• BS. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. An advanced degree is desired, but not required.
• 1+ years of experience in a GMP environment or relevant GMP documentation experience.
• Qualification experience or applicable experience in a related area in the Pharmaceutical industry.
• Proficiency in standard word processing software and project management software is required.
• Mandatory professional skills including knowledge of cGMPs for biopharmaceuticals, organized and disciplined record keeping, document lifecycle management knowledge, excellent communication skills, an ability to work effectively with others in a dynamic environment, and the ability to self-motivate, multitask, and meet tight deadlines.
• Cross-functional leadership skills
• Knowledge of biopharmaceutical unit operations for production of cell therapies is preferred.

The pay range for this position at commencement of employment is expected to be between $66,000 and $99,000 year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.