Jobs · Management · New York

Director, Safety Scientist Lead - Rare Disease

BioSpace · Tarrytown, NY · 4 wk ago
ManagementFull-time
We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title. Must not include Job ID etc. Must remove boilerplate, EEO, etc. Must preserve all substantive info. Let's parse the posting. Content: - Intro: "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director to join our Global Patient Safety Sciences Delivery team. The Director, Global Patient Safety Sciences Delivery, Rare Disease, serves as the first point of contact for all Rare Disease operations including safety data processing, submission creation, and documentation to ensure completeness, accuracy, and timeliness. This role is responsible for high quality, compliant execution of safety surveillance, signal management, and aggregate reporting activities across the portfolio. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide." - When & Where: Work Location: Tarrytown, NY 4 days per week on site 25% Travel may be required - Discover Your Role: bullet points (actually paragraphs) describing responsibilities. List of responsibilities: - The Director is responsible for the development of their team, which is comprised of Safety Scientists. - The Director will also be expected to work closely with other Directors on driving standardization and consistency in execution of signal detection activities in partnership. - This role will report to the ED, Global Patient Safety Sciences Delivery. - Develop common practices, processes and templates to drive standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and TAs - Ensure compliance and quality management of Safety Sciences Delivery activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools - Lead all aspects of signal detection coordination and signal management process across Rare Disease, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER) - Develop innovative approaches to delivering on core activities that integrate in new technologies, - Analyze aggregate safety data to identify emerging safety issues and patterns, in partnership with Safety Sciences Strategy - Support cross-functional coordination to support high quality, timely, and compliant delivery of benefit-risk assessment for periodic safety reports (e.g., DSURs, PSURs) and support Safety Sciences Strategy in contributing Medical and Safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) where required - Drive development and implementation of relevant training programs for GPS staff, including maintenance of a standardized Safety Sciences training curriculum, proficiency matrix, and knowledge management repository across both Strategy and Delivery - Serve as main point of contact to liaise with Safety Sciences Strategy Rare Disease GPS Leads - Collaborate with key Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data Management) - Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines - Implement talent strategy and leadership development initiatives that raise capabilities across the organization - This Role Requires: - Advanced Degree required in life sciences or healthcare with 12+ years of PV experience, preferably with a focus on Safety Sciences and Rare Disease experience - Strong attention to detail with the ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution across activities - Strong leadership capabilities and presence, interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously - Preferred experience with oversight of operations within a global patient safety organization - Preferred Experience With AI Technologies - Preferred experience leading a matrixed role working across multiple areas of an organization and people management experience - Does this sound like you? Apply now... (application instruction, remove) - We are committed to building a workplace with an inclusive culture... (EEO boilerplate, remove) - Where required, we will provide reasonable accommodation... (remove) - Where necessary, we disclose salary ranges... (some mention of salary ranges but not specific numbers; we should not create Pay section unless posting actually states them. It says "Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience." That's generic, not a specific range. Also later: "For jobs in Canada: this posting is for an existing position. Salary Range (annually)" but no number given. So we should not create Pay section because no specific range given. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. So we should not include Pay, Benefits, Schedule unless specific content. - Benefits: later: "Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits." That's a description of benefits. This is substantive content about benefits. So we should include a Benefits section with that list. - Schedule: "Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location." Not specific schedule. Also earlier: "Work Location: Tarrytown, NY 4 days per week on site 25% Travel may be required". That gives schedule info: 4 days per week on site, 25% travel. That's schedule info. So we can include a Schedule section with that. - Pay: no specific numbers, so omit. - About the role: we could have an About the role section summarizing the intro paragraph. That's substantive. - Responsibilities: we have many bullet points. - Requirements: we have the "This Role Requires" bullet points. - Qualifications: maybe combine with Requirements? But we need to follow headings list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can decide to include only those with content. We have About the role, Responsibilities, Requirements, Benefits, Schedule. Possibly Skills: we could extract skills from requirements (strong attention to detail, leadership capabilities, communication skills, organizational and workload planning, ability to manage multiple projects, oversight experience, AI tech experience, matrixed role experience, people management). Could make a Skills section. But we must not create thin sections; prefer few substantive sections over many thin ones. However we already have many sections. Could combine Skills into Requirements or Qualifications. But the instruction says use headings for those categories if content exists. We have content for Skills (the bullet points). Could make a Skills section. But we must avoid filler. The skills are specific. So we can include Skills. Qualifications: maybe the Advanced Degree requirement etc. Could be Qualifications. But we already have Requirements. Might be overlapping. To avoid duplication, we could treat Requirements as the experience/skills, and Qualifications as education/degree. Let's parse: - Advanced Degree required in life sciences or healthcare with 12+ years of PV experience, preferably with a focus on Safety Sciences and Rare Disease experience -> could be Qualification (education + experience). - Strong attention to detail... -> Skill - Strong leadership capabilities... -> Skill - Preferred experience with oversight of operations within a global patient safety organization -> Skill/Experience - Preferred Experience With AI Technologies -> Skill - Preferred experience leading a matrixed role working across multiple areas of an organization and people management experience -> Skill Thus we could have Qualifications (Advanced Degree + 12+ years PV experience) and Skills (the rest). Requirements maybe not needed. But the instruction says include a section ONLY when posting has real, specific content for it. We have content for both Qualifications and Skills. We could also have Requirements (maybe the "Preferred experience with oversight..." etc). But to avoid thin sections, we could combine Requirements and Skills into one? But we need to follow the headings list; we can choose to include only those we have substantive content for. Let's decide: - About the role: intro paragraph. - Responsibilities: list of duties. - Qualifications: Advanced Degree + 12+ years PV experience. - Skills: leadership, attention to detail, communication, organizational, project management, oversight experience, AI tech, matrixed role, people management. - Benefits: description of total rewards. - Schedule: Work Location: Tarrytown, NY 4 days per week on site 25% Travel may be required. We should not include Pay. Now format: Use

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

    for prose. We need to preserve ALL substantive information; do not invent or summarize away detail. So we must keep the exact phrasing? We can keep the substance but not necessarily verbatim? The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." Means we should not omit details, but we can rephrase? Safer to keep the original sentences/phrases as much as possible, but we can format into lists. We need to avoid boilerplate: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Thus we will exclude the "Does this sound like you? Apply now..." and EEO paragraphs, accommodation, salary range generic, background checks, etc. We must keep the benefits description: "Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits." Keep that. Schedule: "Work Location: Tarrytown, NY 4 days per week on site 25% Travel may be required". Also maybe include the sentence about onsite expectations? That is generic; we could keep the specific schedule info. The line "Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location." is generic; we could omit as it's not specific schedule. But we already have specific schedule. We'll keep only the specific. Now responsibilities: we need to list each duty as

  • . Ensure we capture all. Let's extract responsibilities list exactly as in text: - The Director is responsible for the development of their team, which is comprised of Safety Scientists. - The Director will also be expected to work closely with other Directors on driving standardization and consistency in execution of signal detection activities in partnership. - This role will report to the ED, Global Patient Safety Sciences Delivery. - Develop common practices, processes and templates to drive standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and TAs - Ensure compliance and quality management of Safety Sciences Delivery activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools - Lead all aspects of signal detection coordination and signal management process across Rare Disease, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER) - Develop innovative approaches to delivering on core activities that integrate in new technologies, - Analyze aggregate safety data to identify emerging safety issues and patterns, in partnership with Safety Sciences Strategy - Support cross-functional coordination to support high quality, timely, and compliant delivery of benefit-risk assessment for periodic safety reports (e.g., DSURs, PSURs) and support Safety Sciences Strategy in contributing Medical and Safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) where required - Drive development and implementation of relevant training programs for

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