Coding Strategy Manager - Cambridge based hybrid 3 days a week in office. The Coding Strategy Manager will perform coding and dictionary-related activities with an emphasis on development of MedDRA and WHODrug search term lists.
Responsibilities
1. Development of search term lists associated with MedDRA and WHODrug dictionaries (as well as ICD and SNOMED) and other advanced dictionary-related activities.
2. Manage high-volume medical coding activities without compromising quality or timelines.
3. Typically play an active role in updating CS processes, procedures, practices and tools, including CS metrics and Gilead coding conventions.
4. Code Adverse Event (AE) and medical history (MH) terms with MedDRA Dictionary, and medication terms (CM) with WHODrug in accordance with Gilead coding conventions.
5. Respond to coding-related questions in a timely manner.
6. Perform coding reviews.
7. Ensure meticulous adherence to deadlines. Anticipates events which might impact deadlines and mitigates accordingly. Performs tasks in a timely manner.
8. Contribute to the development and maintenance of Gilead coding conventions and suggests process improvements.
9. Contribute to MedDRA and WHODrug upversioning.
10. Support collection of coding metrics to track coding activities and inform management decision-making.
11. May support mentoring and training new hires and less experienced colleagues on coding dictionaries, conventions, and tools.
12. Participate in internal CS projects.
13. May act as key point of contact with Clinical Data Management (CDM) and other groups within Clinical Data Science (CDS) for certain coding activities.
14. Participate in the Core Coding Committee (CCC) meetings.
15. Ensure own work complies with established practices, policies and processes, and any regulatory or other requirements.
Qualifications
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:
* 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.
* 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.
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