Senior Associate, Regulatory Project Management
Senior Associate, Regulatory Project Management
United Kingdom - Cambridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
The Senior Associate in Regulatory Project Management provides project management support to the IC & GPS (Intercontinental & Global Patient Solutions) and some ACE (Australia, Canada, Europe) regulatory teams. The ACE and IC&GPS regulatory teams are responsible for initial marketing applications, including responses to regulatory questions, launch activities, variations and renewals. The Senior Associate in Regulatory Project Management performs a crucial role in coordinating, tracking and prioritising these activities but does not make regulatory submissions or author regulatory documents.
- Under the direction of a more senior Regulatory Project Manager, the Senior Associate will work closely with ACE and IC&GPS teams to develop and maintain detailed timelines for regional regulatory activities and submissions and effective coordination of the submission management team.
- Foster effective and productive communication among various Regulatory Affairs (RA) groups including Regional Regulatory Leads, Regulatory CMC, Labelling, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate, via proactive networking and facilitation.
- Lead meetings with the cross-functional submission teams to plan, coordinate, prioritise, and track submissions for the region and/or specific countries.
- Prepare and maintain submission plans using MS Project.
- Prepare materials to support the team in developing submission strategies and prioritising activities, such as Visio process maps.
- Prepare and maintain meeting outputs, action logs etc.
- Develop risk management strategies and maintain risk/issue logs.
- Initiate or contribute to local process improvements which have a significant impact on the business and work collaboratively with other functional areas and RA's functions at other sites.
- Demonstrated ability to discuss and negotiate critical strategic issues with colleagues at all levels.
- Ability to prioritise and manage own activities and direct others as required.
- Ability to articulate complex regulatory project management risks and issues with colleagues at all levels.
- Must be capable of leading a small team without direct line-management responsibility.
- Must be comfortable with activities and priorities changing at short notice.
Essential Knowledge, Experience & Skills
- Excellent organization skills and ability to work on several projects simultaneously, to tight timelines.
- Excellent verbal and written communication skills.
- Experience of using MS Project, MS Visio and MS Office, ideally to an advanced level.
- Attention to detail.
- Project management experience.
- Stakeholder management experience.
Desirable Knowledge, Experience & Skills
- Experience of collaborating using Zoom, Microsoft Teams or similar, with colleagues in other countries, particularly where English is not their first language.
- An understanding of pharmaceutical regulatory processes, manufacturing, change control and global distribution systems is an advantage.
- Experience within a regulated industry is preferred.
- Knowledge of agile project management methodologies and experience delivering an agile project.
- Project management qualification such as PRINCE2, PRINCE2 Agile, PMP, APM Associate, PMQ is desirable.
- A degree in a scientific field is preferred.
- Risk management experience preferred.
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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