Director, Safety Scientist Lead - General Medicine
BioSpace · Uxbridge, MA · 3 wk ago
ManufacturingFull-time
We need to output HTML fragment with sections using for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. Must not repeat job title as heading. Remove boilerplate, EEO, etc. Must preserve all substantive info.
Let's parse the posting.
Key info:
- Company: Regeneron.
- Role: Director, Global Patient Safety Sciences Delivery, General Medicine.
- Location: Uxbridge, UK, 3 days per week on site, 25% travel may be required.
- Description: first point of contact for General Medicine operations including safety data processing, submission creation, documentation to ensure completeness, accuracy, timeliness. Responsible for high quality, compliant execution of safety surveillance, signal management, aggregate reporting across portfolio.
- Opportunity to contribute to fast-growing, science-driven organization.
- Develop common practices, processes, templates to drive standardization and consistency in execution of core activities (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 General Medicine, 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 General Medicine 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.
Requirements/Qualifications:
- Advanced Degree required in life sciences or healthcare with 12+ years of PV experience, preferably with a focus on Safety Sciences and General Medicine 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.
Benefits: The posting mentions: "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." Also mentions salary ranges: "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. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits." Also mention: "For additional information about Regeneron benefits in the U.S., please visit ..." and "For other locations, additional information will be provided during the recruitment process."
Pay: Not specific numbers, but mention salary ranges disclosed. The rule: do NOT include Pay section unless posting actually states them. It says they disclose salary ranges, but not actual numbers. Is that considered stating them? It says "Where necessary, we disclose salary ranges for roles in all countries in which we operate." That's a statement that they disclose ranges, but not providing the range. The rule: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Here they say they disclose salary ranges, but not giving the range. That might be considered filler? It's not a specific range. It's a statement that they disclose ranges. I'd interpret that as not providing actual pay info, so we should not create a Pay section. Similarly Schedule: they mention "3 days per week on site" and "25% Travel may be required". That's schedule info (onsite expectation). So we can include a Schedule section with that content.
Benefits: they describe benefits package. That's substantive. So include Benefits section.
Now we need sections: About the role (maybe a brief summary), Responsibilities, Requirements, Qualifications, Skills, Benefits, Schedule. Possibly also "Qualifications" vs "Requirements" overlapping. We need to decide what to put where. The posting includes requirements (advanced degree, 12+ years PV experience, etc.) and also preferred experience items. Also skills: leadership capabilities, attention to detail, interpersonal, communication, organizational, workload planning, managing multiple projects, etc. Also "Preferred Experience With AI Technologies". Also "Preferred experience leading a matrixed role...". We can categorize.
We must not repeat job title as heading. Use
for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. Must not repeat job title as heading. Remove boilerplate, EEO, etc. Must preserve all substantive info.
Let's parse the posting.
Key info:
- Company: Regeneron.
- Role: Director, Global Patient Safety Sciences Delivery, General Medicine.
- Location: Uxbridge, UK, 3 days per week on site, 25% travel may be required.
- Description: first point of contact for General Medicine operations including safety data processing, submission creation, documentation to ensure completeness, accuracy, timeliness. Responsible for high quality, compliant execution of safety surveillance, signal management, aggregate reporting across portfolio.
- Opportunity to contribute to fast-growing, science-driven organization.
- Develop common practices, processes, templates to drive standardization and consistency in execution of core activities (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 General Medicine, 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 General Medicine 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.
Requirements/Qualifications:
- Advanced Degree required in life sciences or healthcare with 12+ years of PV experience, preferably with a focus on Safety Sciences and General Medicine 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.
Benefits: The posting mentions: "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." Also mentions salary ranges: "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. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits." Also mention: "For additional information about Regeneron benefits in the U.S., please visit ..." and "For other locations, additional information will be provided during the recruitment process."
Pay: Not specific numbers, but mention salary ranges disclosed. The rule: do NOT include Pay section unless posting actually states them. It says they disclose salary ranges, but not actual numbers. Is that considered stating them? It says "Where necessary, we disclose salary ranges for roles in all countries in which we operate." That's a statement that they disclose ranges, but not providing the range. The rule: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Here they say they disclose salary ranges, but not giving the range. That might be considered filler? It's not a specific range. It's a statement that they disclose ranges. I'd interpret that as not providing actual pay info, so we should not create a Pay section. Similarly Schedule: they mention "3 days per week on site" and "25% Travel may be required". That's schedule info (onsite expectation). So we can include a Schedule section with that content.
Benefits: they describe benefits package. That's substantive. So include Benefits section.
Now we need sections: About the role (maybe a brief summary), Responsibilities, Requirements, Qualifications, Skills, Benefits, Schedule. Possibly also "Qualifications" vs "Requirements" overlapping. We need to decide what to put where. The posting includes requirements (advanced degree, 12+ years PV experience, etc.) and also preferred experience items. Also skills: leadership capabilities, attention to detail, interpersonal, communication, organizational, workload planning, managing multiple projects, etc. Also "Preferred Experience With AI Technologies". Also "Preferred experience leading a matrixed role...". We can categorize.
We must not repeat job title as heading. Use for each section heading.
We must use - for any list of duties/requirements/benefits, and
for prose.
We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep details like specific documents (DSURs, PSURs, ARM, RMP, SMP), safety monitoring team (SMT), safety surveillance plan (SSP), signal evaluation report (SER), etc.
We must remove boilerplate: EEO statements, accommodation, background checks, etc. Also remove "When & Where Work Location:" maybe we incorporate location into Schedule or About the role? The location is substantive: Uxbridge, UK, 3 days per week on site, 25% travel may be required. That could go under Schedule or maybe a separate "Location" but we only have allowed headings. Could put under Schedule (onsite expectation) or maybe under About the role as a brief note. Since Schedule heading is allowed, we can include location and travel there.
We must not include duplicated lines. Ensure we don't repeat same bullet.
Now craft HTML.
Structure:
About the role
... maybe a short paragraph summarizing role: Director, Global Patient Safety Sciences Delivery, General Medicine, serving as first point of contact for General Medicine operations, ensuring safety data processing, submission creation, documentation completeness, accuracy, timeliness; responsible for high-quality compliant execution of safety surveillance, signal management, aggregate reporting across portfolio; contributes to fast-growing science-driven organization.
Responsibilities
- Develop common practices, processes and templates to drive standardization and consistency in execution of core activities (signal detection, authoring sections for safety documents) across all products and therapeutic areas.
- 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 General Medicine, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER).
- Develop innovative approaches to delivering on core activities that integrate new technologies.
- Analyze aggregate safety data to identify emerging safety issues and patterns, in partnership with Safety Sciences Strategy.
- Support cross‑functional coordination to enable high‑quality, timely and compliant delivery of benefit‑risk assessments for periodic safety reports (e.g., DSURs, PSURs) and contribute medical and safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) as 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 Strategy and Delivery.
- Serve as main point of contact to liaise with Safety Sciences Strategy General Medicine GPS Leads.
- Collaborate with key Regeneron interfaces (Clinical, Regulatory, Medical Affairs, Biostatistics & Data Management).
- Build, coach and scale a high‑performing team; drive succession planning and talent pipelines.
- Implement talent strategy and leadership development initiatives that raise capabilities across the organization.
Requirements
- Advanced degree in life sciences or healthcare.
- 12+ years of pharmacovigilance (PV) experience, preferably with a focus on Safety Sciences and General Medicine.
Qualifications
- Strong attention to detail with ability to assess and optimize safety operations processes, drive consistency, and ensure high‑quality, compliant execution.
- Strong leadership capabilities and presence; interpersonal, verbal and written communication skills.
- Organizational and workload planning skills; ability to manage multiple 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.
We could also include Skills section but we already covered many skills in Qualifications. The instruction says use sections only when posting has real specific content. We have content for Skills maybe separate: "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." That's already in Qualifications. Could combine. But we need to decide if we need a separate Skills heading. The posting includes "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." That's a skill set. Also "Strong attention to detail with the ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution across activities." That's also skill. So we could have a Skills section capturing those. However we already placed attention to detail and leadership under Qualifications. Might be overlapping. Better to follow typical structure: Requirements (education, experience), Qualifications (skills, competencies), Skills (maybe technical). But we can decide to have Requirements (education + experience), Qualifications (leadership, attention to detail, organizational skills), Skills (AI technologies, matrixed role, global PV oversight). However the posting lumps preferred experience with AI technologies, matrixed role, global PV oversight under "Preferred Experience With AI Technologies" and "Preferred experience leading a matrixed role...". Those could be Skills.
Let's define:
- Requirements: Advanced degree + 12+ years PV experience (focus on Safety Sciences and General Medicine).
- Qualifications: Strong attention to detail; ability to assess and optimize safety operations processes; drive consistency; ensure high-quality compliant execution; strong leadership capabilities and presence; interpersonal, verbal, written communication skills; organizational and workload planning skills; ability to manage multiple projects simultaneously.
- Skills: 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.
That seems reasonable.
Now Benefits section: include bullet list of benefits mentioned.
Benefits: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life and disability
- for any list of duties/requirements/benefits, and
for prose. We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep details like specific documents (DSURs, PSURs, ARM, RMP, SMP), safety monitoring team (SMT), safety surveillance plan (SSP), signal evaluation report (SER), etc. We must remove boilerplate: EEO statements, accommodation, background checks, etc. Also remove "When & Where Work Location:" maybe we incorporate location into Schedule or About the role? The location is substantive: Uxbridge, UK, 3 days per week on site, 25% travel may be required. That could go under Schedule or maybe a separate "Location" but we only have allowed headings. Could put under Schedule (onsite expectation) or maybe under About the role as a brief note. Since Schedule heading is allowed, we can include location and travel there. We must not include duplicated lines. Ensure we don't repeat same bullet. Now craft HTML. Structure:
About the role
... maybe a short paragraph summarizing role: Director, Global Patient Safety Sciences Delivery, General Medicine, serving as first point of contact for General Medicine operations, ensuring safety data processing, submission creation, documentation completeness, accuracy, timeliness; responsible for high-quality compliant execution of safety surveillance, signal management, aggregate reporting across portfolio; contributes to fast-growing science-driven organization.
Responsibilities
- Develop common practices, processes and templates to drive standardization and consistency in execution of core activities (signal detection, authoring sections for safety documents) across all products and therapeutic areas.
- 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 General Medicine, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER).
- Develop innovative approaches to delivering on core activities that integrate new technologies.
- Analyze aggregate safety data to identify emerging safety issues and patterns, in partnership with Safety Sciences Strategy.
- Support cross‑functional coordination to enable high‑quality, timely and compliant delivery of benefit‑risk assessments for periodic safety reports (e.g., DSURs, PSURs) and contribute medical and safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) as 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 Strategy and Delivery.
- Serve as main point of contact to liaise with Safety Sciences Strategy General Medicine GPS Leads.
- Collaborate with key Regeneron interfaces (Clinical, Regulatory, Medical Affairs, Biostatistics & Data Management).
- Build, coach and scale a high‑performing team; drive succession planning and talent pipelines.
- Implement talent strategy and leadership development initiatives that raise capabilities across the organization.
Requirements
- Advanced degree in life sciences or healthcare.
- 12+ years of pharmacovigilance (PV) experience, preferably with a focus on Safety Sciences and General Medicine.
Qualifications
- Strong attention to detail with ability to assess and optimize safety operations processes, drive consistency, and ensure high‑quality, compliant execution.
- Strong leadership capabilities and presence; interpersonal, verbal and written communication skills.
- Organizational and workload planning skills; ability to manage multiple 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.