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.
• 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.
• 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.