Medical Writing and Clinical Submissions Associate Director
Viiv Healthcare, MS, United States
Medical Writing and Clinical Submissions Associate Director
Apply locations Durham Blackwell Street time type Full time posted on Posted 2 Days Ago job requisition id 409275
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.
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 Medical Writing and Clinical Submission Associate Director 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.
- Motivate, influence, and manage direct reports, contract workers, other team members and senior stakeholders to effectively author, contribute to and review documents.
- Identify need for external resource support. Negotiate timelines, cost, and onboard external medical writing vendors/Clinical Research Organizations (CROs).
- Focus on process improvement or innovative solutions including technology or AI for achieving accelerated timelines as necessary.
- Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix, ensuring standards are proactively applied across a submission.
Basic Qualifications:
- Bachelor’s degree in Life Sciences.
- 5+ years of experience leading activities or components of a project to meet business and regulatory writing submission needs.
- 5+ years of experience scientific or medical writing experience specifically within the biotech/pharmaceutical industry.
Preferred Qualifications:
- PhD, PharmD, MPH, MS, or other post-graduate degree
- Highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at senior level.
- Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
- Ability to effectively lead and manage projects of increasing scope and complexity.
- Demonstrated familiarity with the role of other disciplines contributing to the overall drug development program.