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

Coding Strategy Manager - Cambridge based hybrid 3 days a week in office

POSITION OVERVIEW:

The Coding Strategy Manager will perform coding and dictionary-related activities with an emphasis on development of MedDRA and WHODrug search term lists* and ad hoc coding activities.

KEY RESPONSIBILITIES:

Development of search term lists associated with MedDRA and WHODrug dictionaries (as well as ICD and SNOMED) and other advanced dictionary-related activities. Manage high-volume medical coding activities without compromising quality or timelines. Typically play an active role in updating CS processes, procedures, practices and tools, including CS metrics and Gilead coding conventions. Code Adverse Event (AE) and medical history (MH) terms with MedDRA Dictionary, and medication terms (CM) with WHODrug in accordance with Gilead coding conventions. Respond to coding-related questions in a timely manner. Perform coding reviews. Ensure meticulous adherence to deadlines. Anticipates events which might impact deadlines and mitigates accordingly. Performs tasks in a timely manner. Contribute to the development and maintenance of Gilead coding conventions and suggests process improvements. Contribute to MedDRA and WHODrug upversioning. Support collection of coding metrics to track coding activities and inform management decision-making. May support mentoring and training new hires and less experienced colleagues on coding dictionaries, conventions, and tools. Participate in internal CS projects. May act as key point of contact with Clinical Data Management (CDM) and other groups within Clinical Data Science (CDS) for certain coding activities. Participate in the Core Coding Committee (CCC) meetings. Ensure 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.

Education & Experience

BA/ BS or advanced degree in life sciences or related field with significant experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Nursing or PharmD is preferred.

*Also called Customized MedDRA Queries and Customized WHODrug queries, or in-house SMQs and in-house SDGs.

Knowledge & Other Requirements

Extensive knowledge of MedDRA and WHODrug dictionaries and medical coding applications / uses. For candidates without experience developing MedDRA and WHODrug search term lists, must demonstrate willingness to learn this activity Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of GCP and GVP. Proven abilities to anticipate events or issues that may impact deadlines and the ability to mitigate accordingly. Proven track record of strong attention-to-detail and good analytical skills, as evidenced by performance and results in previous roles. Demonstrates strong proficiencies in the Microsoft Office suite. Ability to lead and influence programs, projects and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly-matrixed environment. Strong communication and organizational skills. When needed, ability to travel.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 for assistance.

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