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AD, Cell Therapy Operations Manager

About the role.

The AD, Cell Therapy Operations Manager requires up to 60-70% travel to cover the territory of Ohio, Michigan, Indiana, West Virginia and Pennsylvania. This role can be based remotely anywhere in the U.S., if the employee is based near a major airport (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) is defined by the hiring manager.

Key Responsibilities:

• Build strong relationships with internal and external territory key stakeholders to provide best in class customer support. Partner and execute a One Team approach with commercial onboarding teams, including Strategic Account Managers, Kymriah CARES and Apheresis Quality to support implementation of site onboarding as a supplier and end-user of commercial manufactured product.
• Coordinate and guide a One Team approach adhering to GCP with internal and external stakeholders in clinical trial support & site onboarding across teams to include Novartis Medical, Novartis Trial Management, Clinical Customer Support, Apheresis Quality and assigned site Clinical Research Associates to ensure successful clinical trial site participation.
• Provide highly engaged site operations support to approved external site staff with a focus on providing guidance as well as continued training based upon approved Novartis messaging through customer facing with ordering physicians, clinical trial Primary Investigators, BMT coordinators, pharmacy, Infusion Nursing Teams, Clinical Trial Coordinators, as well as apheresis units and cell laboratory staff.
• Ensure that sites provide a high-quality consistent supply of starting material for the GMP manufacturing of Cell Therapy products through assessment, approval, initiation, and monitoring of incoming material batches from assigned territory sites.
• Conduct investigations in partnership with Apheresis Quality within the Novartis quality platform through assigned deviations related to incoming specifications, chain of identity breaches, and other related deviations of Novartis manufacturing specification as well as investigating manufacturing results when requested. Oversight of the end-to-end process of deviations in close coordination with all relevant functions to ensure closure of deviation within the due date assigned to each deviation.
• Deliver onsite support for first order, or any time after due to site inactivity; recent site deviations, or due to significant changes in Novartis processes requiring site refresher training. Onsite activities for first collection or any time after will be dependent upon assessments and can be related to cell collection, cell processing and/or shipment of starting material as well as the receipt of final product through the administration of the final product according to Novartis specifications and processes as well as local laws and regulations
• Ensure best practice sharing amongst Cell Therapy Operations and escalate impediments to onboarding in a timely manner to leadership.
• Conduct Periodic Quality Reviews of sites in accordance with Novartis Standard Operating Procedures and meet all timelines associated (PQRs). Manage follow-up of internal and external activities in collaboration within the Novartis One Team approach.
• Complete internal training as a Certified Novartis Investigator and function fully within the Novartis quality tracking program, in partnership with the Apheresis Quality team to ensure all investigations and/or quality events to site activities are completed/evaluated while providing follow-up including, but not limited, to onsite refresher training to the sites supplying the cell material as appropriate.
• Partner with internal stakeholders in relation to management of final product deviations/issues and implement trainings plans

Essential Requirements:                              

• Bachelor’s degree required in science and/or medical, business, or nursing
• Minimum of 7 years external partner (supplier, customer, contractor) facing role experience and/or leadership experience in healthcare which may include Pharmaceuticals
• Experience in at least one of the following areas: 1) interacting and supporting external partners (e.g., clinical site coordinator, external supplier relations, key account manager); 2) hospital stakeholder management role or a customer facing role in pharmaceuticals; or 3) working in a pharmaceutical or hospital GxP environment (e.g., Medical, clinical, manufacturing, marketing, market access, patient services, hospital, cell processing, or apheresis
• Demonstrated ability to engage and train groups/individuals with confidence while balancing an operational and strategic mindset
• Proven project management experience, with ability to manage several deliverables in parallel
• Comfort with navigating interactions with various subject matter experts across medical and administrative personnel at all levels and in large numbers
• Strong negotiating, observational, listening skills to engage stakeholders at all levels with humbleness and openness
• Ability to travel up to 60%-70% within North America and the ability to arrange travel quickly to meet customer/patient needs onsite at certified treatment centers. Flexibility to work outside regular business hours, including evenings and weekends to attend meetings/conferences as well as site support due to transport of material from different time zones

​ Desirable requirements:

• Direct experience/knowledge related to apheresis, blood or tissue collection, or cryopreservation operations is preferred
• Residency in the territory of Ohio, Michigan, Indiana, West Virginia and Pennsylvania is preferred

Field role with a company car : Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver’s license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

The pay range for this position at commencement of employment is expected to be between $151,200 and $226,800/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.  

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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National Research and Gender Statistics Consultant

Advertised on behalf of.

Juba, SOUTH SUDAN

Type of Contract :

Individual Contract

Starting Date :

Application deadline :.

11-Oct-24 (Midnight New York, USA)

Post Level :

National Consultant

Duration of Initial Contract :

Time left :.

11d 20h 23m

Languages Required :

Expected duration of assignment :.

UNDP is committed to achieving workforce diversity in terms of gender, nationality and culture. Individuals from minority groups, indigenous groups and persons with disabilities are equally encouraged to apply. All applications will be treated with the strictest confidence. UNDP does not tolerate sexual exploitation and abuse, any kind of harassment, including sexual harassment, and discrimination. All selected candidates will, therefore, undergo rigorous reference and background checks.

UN Women, grounded in the vision of equality enshrined in the Charter of the United Nations, works on the elimination of discrimination and violence against women and girls, the empowerment of women, and the achievement of equality between women and men as partners and beneficiaries of development, human rights, humanitarian action and peace and security. UN Women provides support to the Government of South Sudan in meeting its gender equality goals and in building effective partnerships with civil society and other relevant actors. Placing women's rights at the centre of all its efforts, UN Women leads and coordinates United Nations system efforts in South Sudan to ensure commitment to gender equality.

In September 2015, governments united behind the ambitious 2030 Agenda for Sustainable Development, which features 17 new Sustainable Development Goals (SDGs) and 169 targets that aim to end poverty, combat inequalities, and promote prosperity by 2030 while protecting the environment. The 2030 Agenda sets out a historic and unprecedented level of ambition to “Achieve gender equality and empower all women and girls by 2030” (SDG 5), and it includes 37 gender-related targets in 10 other SDGs. It commits to addressing core issues of gender equality, such as eliminating all forms of violence against women and girls, eradicating discriminatory laws and constraints on sexual and reproductive health and reproductive rights, recognizing and valuing unpaid care and domestic work and increasing women’s participation in decision-making.

In this context, UN Women is seeking the services of a highly qualified Gender Statistician to support the entity’s research and data work. The successful candidate will work under direct supervision by the Deputy Country Representative and collaborate closely with the Regional Gender Statistics Specialist based in the East and Southern Africa Regional office in Nairobi and the gender machinery and National Statistics Office in South Sudan. The position will be based in the South Sudan National Bureau of Statistics(SSNBS). 

Duties and Responsibilities

The incumbent will provide strategic and technical advice to the National Bureau of Statistics, ensuring strategic cross-cutting mainstreaming on GEWE while contributing to the achievement of the UN Women’s South Sudan Strategic Note Output 1.1.3: The National Statistical System is strengthened to increase the production, analysis, availability and use of high-quality gender statistics and sex-disaggregated data, to inform decision-making and enable reporting at all levels of government and others closely related to or benefitting from gender statistics and research work as a cross-cutting function.

 The following are the detailed duties and responsibilities of the National Gender and Statistics Officer:

• Design and formulate gender statistics related programme/ project proposals and initiatives with the goal of addressing gender statistical challenges experienced at the country level
• Draft inputs to country strategy documents, briefs, policy dialogue and other documents related to Gender Statistics.
• Provide timely progress and financial reports using results-based management.
• Build and manage relationships with national partners to support the implementation and expansion of the Gender Statistics programme.
• Facilitate coordination mechanisms by maintaining a relationship with the project by providing technical assistance.
• Identify and provide technical assistance for capacity building of SSNBS staff and other partners;   provide technical/ programming support and training to partners.
• Provide technical support in the implementation of programme activities; develop technical knowledge products.
• Manage the monitoring of programme/ project implementation using results-based management tools.
• Review quarterly reports and donor reports, focusing on results, output, and outcomes, with a focus on enriching the reports with relevant gender data.
• Provides technical assistance and contribute to donor and UN Women reports.
• Develop and manage partnerships, including with the National Bureau of Statics in South Sudan, donors, international development agencies, civil society, philanthropic organizations, and the private sector.
• Strengthen UN Women’s partnerships with key regional and national stakeholders, including, UN agencies, civil society organizations and other data collecting organizations in the country to present a wide range of relevant data on gender equality and women’s rights to contribute to the regional and thematic monitoring of SDGs, other publications and other associated communications materials.
• Participate and/or represent UN Women in regional inter-agency statistical forums.
• Develop and implement partnerships and resource mobilization strategies.
• Provide inputs in relevant documentation on donors and potential opportunities for resource mobilization.
• Analyse and research information on donors, prepare substantive briefs on possible areas of cooperation, identification of opportunities for cost-sharing.
• Provide technical inputs to technical inter-agency forums and discussions related to SDGs indicators and monitoring in the region.
• Participate and/or represent UN Women in national inter-agency statistical forums.
• Develop and review background documents, briefs and presentations related to Gender Statistics.
• Represent UN Women in meetings and policy dialogues on issues related to Gender Statistics as necessary.
• Develop gender statistics advocacy strategies and oversee their implementation.
• Identify best practices and lessons learned to guide project improvement and strategy planning.
• Develop knowledge management strategies, products, and methodologies on Gender Statistics.

7. Support the UN Women South Sudan office with any other gender data and statistics work as required. 

Competencies

Core Values:

• Respect for Diversity
• Professionalism

Core Competencies:

• Awareness and Sensitivity Regarding Gender Issues
• Accountability
• Creative Problem Solving
• Effective Communication
• Inclusive Collaboration
• Stakeholder Engagement
• Leading by Example

Functional Competencies

• Strong programme formulation, implementation, monitoring, and evaluation skills
• Strong knowledge of Results Based Management
• Ability to synthesize program performance data and produce analytical reports to inform management and strategic decision-making.
• Strong knowledge of gender statistics and familiarity with the SDGs
• Strong communication skills in spoken and written English
• Strong writing skills and ability to produce a variety of knowledge products for different audiences and purposes.
• Ability to produce impactful communications materials and knowledge products.
• Strong commitment to knowledge-sharing within a multicultural environment

Ability to design and deliver training and other capacity-building strategies in gender statistics Basic project management skill

Required Skills and Experience

Education and certification: 

• Master’s degree or equivalent in Statistics, Demography, Development Economics, International Development or any other relevant field. A first-level university degree with a combination of two additional years of experience can be accepted in lieu of an advanced degree.

Experience:

• 5 years of progressively responsible experience with research, data collection, processing, and analysis.
• Experience in programme design, coordination, management and implementation of a gender statistics programme is an asset;
• Technical experience in Gender Statistics is an added advantage;
• Experience coordinating and liaising with government agencies and/or donors is an asset;
• Experience in working in a computer environment using multiple office software packages. Experience in working with Quantum/PRIMAVERA is an advantage.
• Knowledge of gender issues and women´s empowerment
• Work experience within UN Women and or the UN system is an asset.
• Proven experience with socioeconomic policy analysis and mastery of quantitative and qualitative analysis and methods;
• Experience in drafting quality and timely research reports, policy briefs, and position papers.

Language Requirements:

• Fluency in English is required;
• Working knowledge of the other UN official working language is an asset;
• Working knowledge of Arabic is an added asset.

Application:

All applications must include (as an attachment) the completed UN Women Personal History form (P-11), which can be downloaded from  https://www.unwomen.org/sites/default/files/Headquarters/Attachments/Sections/About%20Us/Employment/UN-Women-P11-Personal-History-Form.doc . Kindly note that the system will only allow one attachment. Applications without the completed UN Women P-11 form will be treated as incomplete and will not be considered for further assessment.

In July 2010, the United Nations General Assembly created UN Women, the United Nations Entity for Gender Equality and the Empowerment of Women. The creation of UN Women came about as part of the UN reform agenda, bringing together resources and mandates for greater impact. It merges and builds on the important work of four previously distinct parts of the UN system (DAW, OSAGI, INSTRAW and UNIFEM), which focused exclusively on gender equality and women's empowerment.

Diversity and inclusion:

At UN Women, we are committed to creating a diverse and inclusive environment of mutual respect. UN Women recruits, employs, trains, compensates, and promotes regardless of race, religion, colour, sex, gender identity, sexual orientation, age, ability, national origin, or any other basis covered by appropriate law. All employment is decided based on qualifications, competence, integrity, and organizational need.

If you need any reasonable accommodation to support your participation in the recruitment and selection process, please include this information in your application.

UN Women has a zero-tolerance policy on conduct that is incompatible with the aims and objectives of the United Nations and UN Women, including sexual exploitation and abuse, sexual harassment, abuse of authority and discrimination. All selected candidates will be expected to adhere to UN Women’s policies and procedures and the standards of conduct expected of UN Women personnel and will, therefore, undergo rigorous reference and background checks. (Background checks will include the verification of academic credential(s) and employment history. Selected candidates may be required to provide additional information to conduct a background check.