Medical Writing and Clinical Submissions Associate Director Job at ViiV Healthca

ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV Healthcare is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on for the prevention and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in prevention, treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV / AIDS is eradicated.

ViiV Healthcare has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic.

We are aware of how much is at stake for those at-risk or affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV Healthcare isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference.

While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV Healthcare, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities.

Are you looking for a leadership role that allows you to lead strategy and accelerate regulatory / clinical submission documents and enhance the medical writing process? If so, this Scientific & Medical Writing Manager role could be an ideal opportunity to explore.

As a Medical Writing and Clinical Submission Associate Director, you will be responsible for applying scientific and operational expertise, and leadership in a matrix organization to design and deliver high quality, fit for purpose clinical documents and key organizational process improvements relating to clinical documents including submissions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

• Serve as the Clinical Submission / MW Asset Lead by providing key contributions to clinical strategy, including knowledge, and understanding of regional and global requirements for delivering clinical / regulatory documents to regulatory authorities.
• Lead a team to develop MAAs, NDAs, Supplements (sNDA / Type 2 variations), CSRs, INDs, PIPs / PSPs, ICFs, DSURs, protocols, Briefing Packages, Agency Responses and other scientific and regulatory documents for submission to regulatory authorities.
• Effectively organize complex content and arguments in clinical / regulatory documents.
• Effectively lead and work within a matrix environment in strategic planning and production of clinical / regulatory documents to support regulatory submissions worldwide, including new chemical entities.
• Successfully plan and implement submissions independently or in conjunction with the MW Director. Provides guidance to submission teams in development of detailed submission plan.
• Demonstrates an ability to quickly assess complex situations and identify issues, apply scientific, operational and submission development knowledge to implement effective solutions.

J-18808-Ljbffr