- Manages a small to mid-size RO LAT team, including responsibilities to hire, develop and retain diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests.
- Takes the lead on operational activities involved in label preparation for regulatory submissions in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
- Working in conjunction with the Global TA Liaisons, may be responsible for implementing labelling changes, such as QRD updates or administrative changes, and completing applicable regulatory submissions, such as Closing Sequences, and ensuring product packaging and associated information is updated and maintained, in accordance with the product license for assigned products and markets.
- Develops and manages relationships with translation vendor(s) and works in partnership with Third Parties to file, track, prepare, maintain, review, and deliver updated translations as required.
- Develops and manages relationships with labelling operations and works in partnership to file, track, review, and deliver updated artwork as required.
- Ensures appropriate use and maintenance for artwork and translations systems.
- Raises, informs, and resolves any issues that may impact labelling, translation, and artwork activities, including submission process or timelines, working with all applicable parties.
- Reviews and maintains awareness of regulatory intelligence relating to labelling, translation, and artwork activities, e.g., changes to Regulatory Agency guidance such as template updates, and advises stakeholders accordingly.
- Leads routine and non-routine labelling changes.
- May manage product information labeling translations and artwork documentation tracking and distribution, including filing, archiving, and retrieval.
- Contributes to the definition, development, and implementation of processes and initiatives to meet the evolving needs of the RO LAT group.
- Support inspection readiness activities when applicable.
- Ensures timely and appropriate communication with relevant parties regarding document filing, tracking and review, and to disseminate applicable information.
- Ensures all own and team activities are performed in accordance with departmental standard operating procedures (SOPs).
- Trains and advises new or less experienced colleagues in various RO LAT policies, practices, processes, systems, and other tools.
- Adheres to regulatory requirements, industry standards and Gilead SOPs, and ensures the same across own team.
- In-depth knowledge of labeling, artwork, and translations regulations and guidance.
- Working knowledge of technical aspects associated with labeling and artwork, such as electronic systems, is preferred.
- Demonstrates increasing familiarity with competitor labeling, CCDS/PI requirements, and ex-EU labeling.
- Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional drug discovery, development, and commercial goals and objectives, including ICH standards and the regulatory requirements for assigned markets.
- Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Strong communication and organizational skills.
- When needed, ability to travel.
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Labelling, Artwork - Cambridge, United Kingdom - Gilead Sciences International, Ltd.
Description
Description
POSITION OVERVIEW:
Regulatory Operations (RO) Labeling Artwork and Translations (LAT) is a core function within Gilead's Global Regulatory Operations organization and acts as a critical strategic partner across cross-functional teams. RO LAT manages, updates, and maintains product information labeling and associated documentation, including translation and artwork for all Gilead products in applicable markets outside of the U.S., China, and Japan. This includes managing and coordinating language translations of product information labeling and associated documentation and supporting development and maintenance of artwork through strong collaborative partnerships, as well as maintaining relevant processes and considering process improvements, to allow efficient and compliant work. RO LAT plays a key role in ensuring product information labeling and associated documentation is fully compliant with governing laws, regulations, and company policies and procedures, while being aligned with business goals and objectives, to facilitate effective review by health authorities and other stakeholders, as well as to avoid errors in product information labeling to protect patient safety. RO LAT works closely with cross-functional partners to ensure timely and appropriate delivery of product information labeling translations and artwork updates, including other Regulatory and Development teams, Legal, Commercial, and external third parties i.e., translation vendor and regulatory agencies.
You will manage a small to mid-size team of direct reports supporting translation and artwork activities involved in the preparation and maintenance of updates to ex-U.S. product information labeling for multiple products. You will take the lead on preparation and maintenance of non-routine/more complex product labeling, artwork, and translation activities for assigned products in ex-U.S. markets. You will be accountable to ensure timely, thorough, high quality, and compliant preparation, maintenance, and review of EU annexes and ex-U.S. labeling, including oversight of all support provided by your team in associated regulatory submissions. You will represent RO LAT on Regulatory Project Teams, in cross-functional submission team meetings, and on joint labeling/safety meetings with partner companies. You will act as the main point-of-contact for assigned products and markets. You will contribute to the regulatory review of Annual Reports and safety reports as applicable. You will maintain awareness of regulatory intelligence and guidance, as this impacts product labeling, artwork, and translations, and educate internal/external partners on these matters and their evolution. You will support inspection-readiness activities. You may also initiate process updates and/or other special projects.
EXAMPLE RESPONSIBILITIES:
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Rest of World Education & Experience
BA/ BS or advanced degree in life sciences or related field with significant regulatory or related experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Prescription drug labeling or related work experience.
Knowledge & Other Requirements
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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