Associate Director, Medical Coding - GCO Clinical Data Management
Parsippany, United States, New Jersey, 07054
Who we are
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
The opportunity
The Associate Director, Medical Coding is responsible to plan, lead, manage and oversee the medical coding infrastructure and activities of Teva’s development programs across all indications from Phase I to Phase IV, in terms of cost, quality, timeliness and efficiency, while assuring patient safety and data quality and integrity.
How you’ll spend your day
Essential Duties & Responsibilities:
1. Leads, manages, and oversees activities related to the delivery of complete, accurate and consistent medical coding for all supported clinical trials for reporting and analysis.
a) Supervises direct reports who are responsible to lead and manage and provide oversight of coding tasks performed by outsourced service providers to ensure milestones, deliverables, quality, and timelines are met.
b) Ensures all coding activities and deliverables for all studies are completed in line with business requirements, company objectives, within budget and in accordance with regulatory requirements.
2. Develops and maintains related processes, guidelines and conventions and coding infrastructures.
a) Develops and maintains coding infrastructure for both internal and external coding model to provide coding and oversight activities, including administration of relevant internal coding systems where applicable.
b) Develops and maintains internal coding reports to assist in providing coding oversight reviews and consistency checks for quality coding deliverables.
c) Develops, maintains, and ensures compliance of global coding MedDRA and WHODrug coding conventions to promote consistency, accuracy, and quality coding. Ensures relevant training and ongoing support to internal and external coding teams.
d) Leads the department development of SOPs, procedural documentation, and continuous process improvement in collaboration with Strategic Planning and Process Management and relevant stakeholders.
e) Identifies areas for innovation and potential supporting technologies.
4. Acts as Business Owner and Point of Contact for Company Global MedDRA and WHODrug dictionary licenses, renewals, budgets, and relevant user access to dictionary files.
5. Maintains and develops dictionary version implementation plans for supported clinical development studies and the integrated clinical safety database, as necessary, in accordance with SOPs, guidelines and standard conventions.
6. Supports collaboration, communication, coordination, and prioritization within the department, across the organization, and with services partners.
7. Leads initiatives and represents GCO/Data Management as a key stakeholder in global cross-functional initiatives.
8. Recruits, selects, develops, trains, manages, motivates, coaches, and appraises the performance of direct reports. Builds team commitment to goals and creates a positive and productive culture within the team.
9. Follows Teva Safety, Health, and Environmental policies and procedures.
10. Performs other duties as requested by management and conducts special projects as assigned.
Your experience and qualifications
Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
Education Required: Required: Bachelor or higher degree in science or PharmD with medical/clinical experience is required. Candidates with lesser education may qualify if experience and demonstrated skills are commensurate.
Experience Required: Associate Director must have 10 or more years of medical coding experience in a pharmaceutical or clinical research setting. Strong management and supervisory experience in a global setting, medical coding environment within the pharmaceutical industry.
Well versed in trends and emerging industry dynamics concerning coding in the pharmaceutical industry.
Expert knowledge of coding dictionaries, coding applications and industry standards, including but not limited to: MedDRA, WHODrug, Standardised MedDRA Queries (SMQs), Standardised Drug Groupings (SDGs), MedDRA Version Analysis Tool (MVAT), WHODrug Change Analysis Tool (CAT), WHODrug Insight, MedDRA Web-based browser.
Working knowledge of various coding systems applications, including but not limited to Rave Coder, Veeva Vault, TMS, etc.
Extensive knowledge of GCPs and ICH guideline.
Strong experience in vendor and CRO management in the pharmaceutical industry.
Experience in process improvement and design as well as project management and budget expertise.
Good Information Technologies orientation.
Excellent written and oral communication skills.
Proven success working in a virtual, global, and multi-cultural environment.
Compensation Data
The annual starting salary for this position is between $166,000 – $208,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.
How We’ll Take Care of You
At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.
When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
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Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.