Medical Writing Manager(Regulatory experience required)

4 weeks ago

United Kingdom Gilead Sciences, Inc. Full time

Manager, Quality Management - Patient Safety
Manager, Quality Management - Patient Safety
United Kingdom - Cambridge Pharmacovigilance & Epidemiology Regular Job Description
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.

Join Gilead and help create possible, together.
Manager, Quality Management within Strategic Operations, Patient Safety
The Patient Safety (PS) department is a global function that is part of the Development organisation within Gilead. This role is based in Cambridge in the PS Strategic Operations (SO) team, which is responsible for ICSR excellence & operational support of clinical studies, PS alliances & vendor management, operational standards & audit and inspection readiness/support, PS process & training deliverables, medical device expertise and PS systems.
This role is part of the Standards & Inspection Readiness Team, which is the team that establishes standards and targets for quality across operational deliverables for both in-house and outsourced activities, monitors and trends against key performance indicators, maintains inspection readiness across SO and leads inspection and audit activities for SO related processes.
Oversight of ICSR QC activities and production of the PS Strategic Operations QC report.
Oversight of QC responsibilities that are outsourced or delegated to junior staff members, ensuring quality and accuracy and timeliness of deliverables.
Establishment of new standards, trending and development of new QC strategies.
Expectations for the above activities includes understanding of global PV regulatory requirements related to the collection, processing and submission of ICSRs both from the clinical trial and post-marketing setting, knowledge of end-to-end ICSR processing, PS interfaces with internal and external sources of safety data, experience in assessment of high-volume and highly complex data sets, solution-oriented cross-functional collaboration.
Liaises with various internal and external groups to maintain a high level of quality and consistency across functional teams on best practices and industry standards.
Co-authors the monthly Operations QC reports for both in-house and outsourced ICSRs.
Takes lead for assigned projects and is fully responsible for all activities relating to them.
Provides input into ICSR Quality Management inspection readiness activities and storyboards as required.
Significant experience analyzing, interpreting and reporting data / information in a PV environment.
Significant experience working with drug safety / PV or related systems, databases, and tools.
Strong analytical thinking skills and attention-to-detail, as evidenced by the ability to effectively assess high-volume and highly complex data sets and accurately determine performance levels, quality and compliance implications and make appropriate recommendations to remediate issues and optimize performance.
Strong communication and writing skills and proficiencies with Microsoft Office suite, as evidenced through abilities to assume assignments and projects with increasing independence.
Able to act as lead representative on cross-functional teams and/or projects, and internal audits.
May lead or contribute towards special projects such as developing new departmental methodologies, templates, other tools, continuous improvement, etc. BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment, including experience working with medical terms and exposure to GCP and GVP.
Resource and workload management experience.
Has an excellent knowledge and understanding of applicable global regulatory requirements.

Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.We promote and support individual differences and diversity of thoughts and opinion.
Full Time/Part Time Full-Time

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