דרושים Manager-senior Manager Sales Operations ב-Incyte ב-ארהב

Job Summary (Primary function)
The Sr. Biologics CMC (Chemistry, Manufacturing, and Controls) Writer will be primarily responsible for authoring CMC sections of global regulatory submissions including BLA, IND, IMPD, MAA as well as working with other technical documents (e.g.. Redlining/SOC reports). The position will manage work independently with members of the Biologics Pharmaceutical Development group as well as other functional areas within the organization, including external collaborators, to complete the full package ready for submission.

Essential Functions of the Job (Key responsibilities)

• Contribute to the phase appropriate development strategy for the Biologics portfolio.
• Write and edit CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide. Experience with authoring Module 3 CTD sections for IND and BLA is highly desirable.
• Collaborate with subject matter experts to write and edit other manufacturing related controlled technical documents using a uniform style and language for regulatory compliance.
• Coordinate authoring and review activities with the functional areas within Global Biopharmaceutical Development and Quality Assurance to reach alignment and to meet deadlines for Regulatory Submissions.
• Work closely with Regulatory Affairs to establish priorities and ensure successful completion of regulatory submissions to Regulatory Operations.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Degree (such as BS/MS/PhD) in Engineering or Biological Sciences or equivalent experience and in the biotech related industry.
• Several years of experience in Biologics technical writing as a SME in Analytical, Formulation, or Process Sciences, in authoring CMC sections of global regulatory filings.
• Technical knowledge of and experience in monoclonal antibody development is a plus.
• Experience with working collaboratively with other departments such as technical teams, Quality Assurance and Regulatory Affairs.
• Proven track record on regulatory submissions of biological products.
• Demonstrate competency in clear and concise technical writing ability.
• Must be well organized, flexible, with excellent cross-functional communication skills that encourages inclusion and welcomes diversity of thought among stakeholders.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary

·Participate in internal site contract efficiency improvement initiatives

·For assigned sites, serve as a primary site contract contact for country/regional end-to-end study site contract activity

·Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to site contract activity

·Utilize systems and tools to track assigned activities and produce reports and metrics as needed

·Responsible for site contract collection, tracking & review

·Responsible for the collection of country and site level intelligence

·Where required, complete, manage and/or support country/region and site-specific site contract activities (e.g., electronic medical record access agreements, site payment activities, budget escalations) required to activate or maintain sites for a study as appropriate

·Other duties as assigned

Minimum Requirements

·Preferred Bachelor’s Degree in Business Administration, science or related field or work experience equivalent

·Minimum of three years of relevant experience in site contracts and/or payments

·Ability to negotiate intermediate contract and payment terms

·Flexibility to assume a workload which frequently necessitates an adjustment of priorities

·Goal oriented, self-starter with proven ability to work independently

·Able to proactively identify issues and provide potential solutions for resolution

·Detail oriented

·Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines

·Proficiency with all applications of Microsoft Office

·Good interpersonal skills

·Comfort with ambiguity; ability to act without having the total picture

·Excellent oral and written communication skills in English and other local language(s) as applicable

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Essential Functions of the Job (Key responsibilities):

• Oversee, develop, and maintain written scientific information for use in responding to unsolicited customer requests; explore opportunities to leverage AI solutions.
o Manage external vendors involved in scientific content development.
• Creation of medical information standard response letters, product dossiers, and frequently asked question (FAQ) documents
• Serve as an active member on cross-functional teams (e.g., promotional materials review committee, core medical team, scientific materials review committee).
• Provide medical literature surveillance for Medical Affairs; communicate pertinent updates in a timely manner.
• Support medical conference activities, including execution of pre- and post-conference deliverables, insights generation, and staffing of medical/scientific booth.
• Collaborate with cross-functional partners (eg, Research & Development, Publications & Medical Communications); assist with development of scientific exchange materials for emerging therapeutic areas.
• Develop and maintain expertise in relevant hematology and oncology therapeutic areas, including disease states, treatment landscape, and ongoing research strategies.
• Assist Medical Information Leadership with key projects, as needed.
• Comply with all guidelines, policies, legal, regulatory, and compliance requirements.

Qualifications (Minimal acceptable level of education, work experience, and competency):

• Healthcare Professional (PharmD, MD, RPh, PhD in related field) with 2-5 years' experience working in a Medical Information/Medical Affairs capacity for a pharmaceutical or medical device company, or equivalent clinical experience, is required.
• Knowledge of FDA regulations regarding the dissemination of Medical Information, drug promotion, and adverse event and product quality complaint reporting, is required.
• Experience creating scientific content, including medical information response letters and clinical slide presentations, is required.
• Ability to query scientific literature (via PubMed, Embase, Scopus, etc.) and identify and summarize pertinent findings is required.
• Excellent oral and written communication skills are required.
• Excellent project management skills, including the ability to plan, prioritize, and execute multiple projects are required.
• Experience in hematology/oncology is strongly preferred.
• Approximately 15% travel commitments.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary

The Senior Director, Market Access Operations is a critical leadership role responsible for developing and executing operational strategy and advanced analytics that enable patient access and payer engagement across the U.S. organization. This individual will oversee HUB, Payer and copay analytics to drive performance, field enablement, and data-driven decision-making. The Executive/Senior Director will partner cross-functionally with Market Access, Product Strategy, Finance, and Sales to deliver market access insights and operational excellence in a dynamic and evolving healthcare landscape.

Essential Functions of the Job (Key responsibilities)

·Lead, mentor, and develop a high-performing team of market access operations and analytics professionals, fostering collaboration, accountability, and innovation.

·Lead performance monitoring across all market access functions and provide regular executive updates on trends, opportunities, and risks.

·Oversee all aspects of Market Access operations and analytics, ensuring accuracy, integrity, and compliance with legal, regulatory, and corporate standards.

·Design in partnership with market access leadership team KPIs and performance metrics to evaluate Field Access Manager effectiveness, account pull-through activities, access education, and patient case resolution.

·Provide integrated, actionable insights to senior leadership and cross-functional stakeholders to shape market access strategy and execution.

·Collaborate with Data Management, BIS, and market access vendors to enhance data acquisition, governance, and processing pipelines supporting access operations.

·Inform on going access-related brand planning and go-to-market strategies using evidence-based analytics.

Qualifications (Minimal acceptable level of education, work experience, and competency)

·BA or BS degree or equivalent experience, degrees in mathematical background preferred.

·Extensive years of experience in Market Access, Commercial Analytics, or Operations within the pharmaceutical/biotech industry.

·Proficiency with market access data sources

·Expertise in analytics for Hub services, copay programs, payer dynamics, and field access models (FAMs, PAMs)

·Experience in managing and developing direct reports. Proven experience in motivating high performance teams and versed in techniques for effective coaching, communication, and working styles.

·Proficient in all aspects of analyzing healthcare sales data and field activities.

·Proficient in customer relationship management systems for Market Access teams

·Excellent verbal, written and stakeholder management skills to effectively influence and manage expectations with sales management and cross-functional teams.

·Strong project management skills.

·Willingness to travel up to 20% domestically

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Essential Functions of the Job

• Business owner of consumer and Market Access Digital Performance Dashboards: design dashboards for each brand with accurate, actionable, and meaningful data visualizations, and align cross-functionally to evolve the dashboard in alignment with the MCE strategy and brand goals
• Dive into the data to run ad hoc analysis to answer key business questions, such as inflight performance and the impact of tests & optimizations
• Lead monthly & quarterly reporting of consumer digital performance for each brand to internal stakeholders & agency partners by translating data into insights and recommendations
  Collaborate with team members to create measurement plans with clear and specific objectives aligned to each brand's goals for cross-channel, within channel, and campaign/tactic effectiveness, ensuring inclusivity and diverse perspectives in the planning process.
• Lead project/tactic measurement planning by identifying and gaining alignment on meaningful outcome metrics and set specific goals before build & deployment
• Support the creation & delivery of presentations to various stakeholders to support brand planning/budgeting, competitive prep, brand launches, and other key brand decisions
• Explore and evaluate new data sources/platforms

Qualifications

• A bachelor's degree or equivalent experience is preferred.
• 4 to 6+ years of experience in digital marketing analytics in any industry.
• 2 to 4+ years of experience with presenting analytics/insights to business end users.
• Strong communication, presentation, reasoning, and storytelling skills.
• roficiency with data analytics, visualization, interpretation.
• Hands-on experience with web analytics tools (e.g., Google Analytics, Adobe, etc.)

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

Essential Functions of the Job (Key responsibilities)

·Assists in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.

·Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.

·Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Logistics group.

·Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.

·Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.

·Plan and organize meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.).

·Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.

·Participate in data review and discrepancy resolution.

·Participate in coordinating efforts with internal Pharmacovigilance, and safety group.

·Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc).

·Participate as a member of the multi-disciplinary trial(s) team.

·Develop relationships with investigational sites and institutions to enhance conduct of the trial.

·Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.

·Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.

Qualifications (Minimal acceptable level of education, work experience, and competency)

·BS/BA degree or a relevant degree with strong emphasis on science.

·Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience.

·Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.

·Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

·Prior experience in assisting the conduct and management of multinational clinical trials is preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .