Senior Manager, Epidemiology

for section headings. Use

• for any list of duties/requirements/benefits. Use

  for prose. We must not repeat job title as heading. Not include Job ID etc. We must remove boilerplate: EEO, internal career site note, etc. Also remove navigation/legal etc. The posting includes "If you are a current Jazz employee please apply via the Internal Career site." That's application instruction; remove. Also remove "Jazz Pharmaceuticals is an equal opportunity/affirmative action employer..." etc. Also remove "FOR US BASED CANDIDATES ONLY ..."? That's part of compensation description but includes some info about pay range. Actually the compensation paragraph includes that. We need to keep the pay range and bonus info but remove the US based candidates only? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The "FOR US BASED CANDIDATES ONLY" is not exactly EEO but could be considered a restriction; but it's part of compensation description. Might be considered boilerplate? It's a statement about US based candidates only; but the pay range is given for US based candidates. Might be relevant. However the instruction says remove EEO/equal-opportunity/scam-warning boilerplate. This is not exactly that. It's a location restriction. Might be considered part of the posting; but we could keep it as part of Pay section? It says "For US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices..." This is a bit of boilerplate but also includes pay range. We could keep the pay range and bonus info, but drop the "FOR US BASED CANDIDATES ONLY" sentence if it's considered boilerplate. However the pay range is only for US based candidates; but we can still mention the range without specifying US only. The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. If we drop the "FOR US BASED CANDIDATES ONLY", we are removing a detail (that it's US only). That might be considered substantive. But the instruction says remove boilerplate; this could be considered boilerplate. I'd lean to keep it as part of Pay section, but we can phrase as "For US-based candidates, the base pay range is $141,600.00 - $212,400.00". That retains the info. Similarly benefits: we have description. Now we need to ensure we don't include duplicated lines. Let's extract content. About the role paragraph: we have the brief description. We'll put that in

  . Responsibilities: list of bullet points from "Essential Functions/Responsibilities". Let's capture each bullet: - Conduct/outsource literature searches to identify epidemiology data on disease incidence, prevalence, mortality, natural history, and cross-sectional studies describing the demographics, co-morbidities, treatment patterns and concomitant medications of the target patient populations in different geographies - Contribute epidemiology data to regulatory submissions supporting Clinical Development Programs (e.g., RMPs, safety query responses, orphan drug applications, pediatric waivers, and external control arms) and other processes requiring epidemiological data - Provide top of the patient funnel data for forecasting/commercial purposes - Identify appropriate US and EU secondary data sources for studying the target patient populations (e.g., administrative claims and electronic medical records (EMR) databases) - Lead Requests for Proposal (RFP) and Statement of Work for soliciting proposals and budgets from CROs and Data Providers for outsourced epidemiology studies - Support a multi-disciplinary non-interventional Phase IV study team to deliver study-related regulatory submissions (e.g., protocols, statistical analysis plans, progress reports, interim study results and final study reports) in accordance with applicable regulatory guidelines and the PMR/PMC timetable set by a Health Authority - Develop statistical analysis plans in collaboration with the project biostatistician (including those for analyses of administrative claims and EMR databases) - Manage external investigators, project managers and operational leads at Contract Research Organizations (CROs) and/or Data Providers for outsourced studies to deliver high-quality results on time - Communicate effectively with the US and EU Regulatory Leads on the timetable and status of all submission deliverables to fulfil a PMR/PMC - Develop strong partnerships with internal stakeholders (e.g., Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs) to ensure that the appropriate epidemiological support is provided in their respective processes - Communicate study plans, project timelines, budget projections, progress reports, interim and final study results to internal Jazz teams on time - Present research findings at scientific congresses and co-author manuscripts for publication in peer-reviewed journals. - Ensure compliance with all applicable laws, regulations and regulatory guidelines We need to keep each as

• . Now Requirements: "Required Knowledge, Skills, And Abilities" list: - Advanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences) - At least 2 years of experience in the pharmaceutical industry, CRO or in academia - Experience with rare disease studies - Project management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research study - Experience successfully coordinating cross-functional processes - Experience analyzing secondary data sources (administrative claims and EMR databases) - Excellent oral and written communication skills in English - Solid understanding of epidemiology and biostatistics - Experience managing multiple projects and reprioritizing work when necessary - Capable of working remotely with minimal supervision - Proficiency with MS Word, Excel and PowerPoint - Ability to travel approximately 10% time We'll put these as
  • . Qualifications: "Required/Preferred Education And Licenses" list: - Therapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platform - Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews) - Experience conducting post-marketing safety studies of marketed medicines - Experience supporting Clinical Drug Development, Safety, Forecasting and Medical Affairs teams within a biopharmaceutical company - Experience authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to FDA, EMA and other health authorities - Data analysis programming skills (SAS, Stata, R) or recent hands-on experience using an RWE platform technology We'll put as
    • . Benefits: The paragraph: "The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation." Also earlier: "The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan." That's more compensation but could be part of Benefits or Pay. We'll treat bonus/equity as part of Benefits? Actually they said "total compensation package" includes base pay, bonus, equity, benefits. We have Pay section for base pay. Benefits section for medical/dental/vision, 401k, vacation. Bonus/equity could be part of Benefits or Pay. Since we have Pay section for base pay, we could put bonus/equity in Benefits as additional compensation. But the instruction: Benefits section only if posting actually states them. It does state benefits offerings. It also states bonus and equity grants. We could include them in Benefits as well. Or we could create a separate Compensation section but not in list. We'll include bonus/equity in Benefits. Thus Benefits
      • items: - Medical, dental and vision insurance - 401k retirement savings plan - Flexible paid vacation - Discretionary annual cash bonus or incentive compensation (according to Global Cash Bonus Plan or Incentive Compensation Plan) - Discretionary equity grants (according to Long Term Equity Incentive Plan) We need to preserve the wording. Pay: The base pay range: "$141,600.00 - $212,400.00". Also mention that individual compensation depends on factors, goal etc. We should preserve that substantive info. So we can put a

        with that description. We must not include the "FOR US BASED CANDIDATES ONLY" maybe we can incorporate as part of Pay: "For US-based candidates, the base pay range is $141,600.00 - $212,400.00". That retains the info. We also have statement: "Individual compensation paid within this range will depend on many factors, including qualifications,