Associate Director, Medical Writing Job at Jobleads-US in Foster City
Jobleads-US, Foster City, CA, United States
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional drug discovery, development and commercial product lifecycle management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world.
We have an exciting and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory documents independently, including novel or atypical documents which require ingenuity and considerable medical writing expertise and autonomy. You will define the Medical Writing strategy, plans, and objectives for assigned products or projects. You will represent Medical Writing on relevant product, project, and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other cross-functional initiatives. You may serve as the filing lead for large complex regulatory submissions and as lead medical writer for a large development program or TA. You will participate in or may lead Medical Writing and cross-functional process improvement initiatives on regulatory document standards, template development, and document process. You may manage or supervise direct reports and contractors, overseeing recruitment and on-boarding.
EXAMPLE RESPONSIBILITIES:
Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs) (all phases), investigator’s brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.
Typically represents Medical Writing and participates in multiple cross-functional teams, such as regulatory submissions and/or other regulatory project teams and provides guidance on regulatory submission document strategies.
Plans and oversees all assigned deliverables. May serve as a filing lead for large complex regulatory submissions, with responsibilities including development and management of document timelines and resource planning for assigned projects.
May serve as a senior medical writer and department representative for a large development program or TA, including providing guidance to less experienced Medical Writing colleagues or contractors working on the same projects.
Participates in or may lead Medical Writing and cross-functional process improvement initiatives on document standards, template development, and document processes.
May also participate in other special projects and/or represent Medical Writing in other cross-functional initiatives.
Where applicable, oversees the work of external contractors supporting Medical Writing deliverables and other activities.
Typically coaches, trains, and provides guidance to less experienced Medical Writing colleagues. Leads or advises others on complex projects or problems with broad impact and reviews documents written by less experienced or contract medical writers.
May manage one or more direct reports. Appropriately delegates projects and initiatives to team and identifies potential conflicts and proactively takes action to mitigate.
Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
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.
U.S. Education & Experience
PharmD/PhD with 6+ years’ relevant experience.
MA/MS/MPH/MBA with 8+ years’ relevant experience.
BA/BS with 10+ years’ relevant experience.
Significant medical writing, regulatory, quality, clinical R&D, or related experience in the biopharma industry.
Proven track record in effectively setting and directing the medical writing or related strategy to successful conclusion for one or more products.
Experience authoring a broad range of regulatory, scientific, and/or medical documentation across multiple stages of drug development.
Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
Where applicable, line management (direct reports) experience is preferred.
Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred.
Rest of World Education & Experience
BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry. Experience leading a broad range of medical writing or related deliverables and setting the medical writing or related strategy for biopharmaceutical products.
Knowledge & Other Requirements
Recognized as a subject matter expert in a broad range of regulatory documentation and a resource for specialist advice and guidance.
Demonstrates in-depth knowledge of current global and regional trends in medical writing and regulatory and is able to apply this to advance and accelerate medical writing strategies for assigned products or projects.
Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understand and effectively advise on its implications. In-depth knowledge of relevant health authorities, including system, processes, and requirements.
Able to advise cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
When needed, ability to travel.