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Design Space InPharmatics, a leading international pharmaceutical consulting organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio of drug development clients. We are looking for a consultant with demonstrated expertise authoring and compiling FDA New Drug Application (NDA) submissions, specifically NDA Module 2 and Module 5 content in CTD/eCTD format. The ideal candidate will bring strong experience in clinical regulatory writing, integrated summaries, clinical study report development, and NDA submission strategy across small molecule and/or biologic drug products. This is a high-impact consulting engagement offering flexibility, and meaningful work at the forefront of regulatory drug development. Role and Responsibilities In this high-impact consulting role, the Regulatory Medical Writer will provide expert-level authoring and regulatory documentation support across a range of FDA NDA submission programs. Working remotely within a collaborative consulting team, the successful candidate will: • Author, edit, and compile NDA Module 2 clinical summaries and overviews, including Clinical Overview (Section 2.5), Clinical Summary (Section 2.7), Benefit-risk assessments and Integrated summaries of safety and efficacy., • Prepare and/or manage NDA Module 5 clinical documentation, including Clinical study reports (CSRs), Protocols and protocol amendments, Statistical analysis plans (SAPs), Case report tabulations, and listings coordination., • Ensure all documents comply with FDA guidance requirements, ICH CTD/eCTD standards, Good Clinical Practice (GCP), and internal quality and style standards., • Participate in submission planning, document gap assessments, and submission readiness reviews., • Support the preparation of responses to FDA information requests and review comments., • Coordinate timelines and deliverables to support NDA submission milestones., • Collaborate cross-functionally with clinical development teams, biostatistics, data management, pharmacovigilance, regulatory affairs, and medical affairs., • Function as a trusted regulatory writing subject matter expert within client project teams and CMO relationships., • Proactively flag gaps or risks relative to FDA expectations or industry best practices. Qualifications and Education Requirements • Advanced degree preferred (PharmD, PhD, MD, MS, or equivalent scientific discipline), Minimum 8–10 years of pharmaceutical or biotechnology regulatory writing experience., • Direct, hands-on experience authoring FDA NDA Module 2 and Module 5 content., • Strong knowledge of FDA NDA submission requirements, ICH E3 and CTD/eCTD structure, clinical trial documentation standards, and drug development processes. Preferred Skills • Experience with small molecule drug development programs., • Demonstrated expertise preparing integrated summaries of safety (ISS) and integrated summaries of efficacy (ISE)., • Familiarity with publishing systems and eCTD submission platforms., • Prior interaction with FDA review teams or support during regulatory agency meetings., • Consulting experience supporting multiple sponsors or parallel drug development programs., • Excellent scientific writing, editing, and data interpretation skills., • Ability to work independently and manage multiple deliverables in a fast-paced consulting environment. Additional Notes • Candidates who bring experience across both small molecule and biologic programs, or who have supported multiple NDA submissions across different therapeutic areas, will be especially well regarded. The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. DSI reserves the right to amend this description as client program needs to evolve., • This is an excellent opportunity for a seasoned regulatory writing professional seeking to apply their expertise within a dynamic, market-leading consulting organization at the forefront of pharmaceutical regulatory strategy and drug development services., • This is a fully remote, independent consultant role. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs., • All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.

Job Title: Management consultant. Collaborate remotely with the customer’s team to support the training and evaluation of AI models with real-world management consulting perspectives. Minimum of 4+ years’ experience as a management consultant, ideally with a top-tier consulting firm.

Proven ability to manage multiple projects and meet stringent deadlines in a fast-paced remote environment.

Strong organizational skills and the ability to manage multiple projects remotely.

Collaborate with a dynamic remote team to improve model performance and reliability through hands-on assessments. Experience with cross-functional or cross-disciplinary project teams in a remote environment.

Job Description Job Title: Senior Mechanical Engineer - Data Center Facilities Job Type: Full-time Job Location: On-Site Edison, NJ (this is not a remote or hybrid job). Company Information: Growing NJ Data Center Information Technology/Design/Engineer Firm that delivers an industry-leading portfolio of consulting, design/build, and commissioning services for organizations seeking to plan and deploy an agile IT infrastructure. Mobile. Social. Big Data. Analytics. Artificial Intelligence/High Performance Compute included. These are the business trends we help clients address. Description of Role: We are seeking a skilled Sr. Mechanical Engineer PE with 7+ year design experience for data center/mission critical project experience working with a team on ongoing and new projects. Individuals must have clear written and oral communication skills, detail oriented and up-to-speed software systems utilized in this field. Working alone or with additional team members with the ability to multi task and work successfully under pressure to achieve client deliverables. Knowledge of Cooling Towers, Glycol Systems, Air Cooling Systems, In Row Cooling, Rear Door Heat Exchange, BMS Control, Plumbing, Fire Protection, AutoCAD. Tasks include but not limited to: • · Professional Engineering design of the mechanical engineering discipline, including HVAC, Plumbing and Fire Suppression., • · Development of design solutions for discipline, using sound engineering principles and practices., • · Providing calculations and related documentation for designs developed and implemented and maintenance of documentation for future reference., • · Evaluation of existing facilities and systems respective to the as-built conditions which affect the design., • · Providing written reports documenting design criteria and other aspects of the design., • · Suggesting alternate solutions based upon life cycle and/or first cost basis with associated budget impacts., • · Coordination of consultant and in-house design and CADD personnel to accurately document the design intent on the construction and bid documents., • · Sealing of permit documents as Engineer of Record. (The company will furnish E & O and liability insurance). Company Insurance coverage will not cover any design for an outside project not related to the Company., • · Other responsibilities normally performed in the execution of mechanical design on a professional level, according to standard industry practices., • · Travel to project job sites will be expected. Skill Requirements: Bachelor’s degree in Mechanical Engineering and Licensed/Registered. Have the ability to interact with the comprehensive multi discipline team on consulting reports, design projects, and construction/commissioning projects. Work Schedule: • This is a full-time job position. In office, not remote or virtual., • Normal business hours are Monday thru Friday 8-5pm., • This role requires project related travel. Benefits: • · Salary is based on skill and experience., • · Comprehensive Benefits which include Medical, Dental, Vision, Life Insurance and paid time off., • · 401K Match to $3,500, • · Performance Awards, • · Longevity Plan, • · Year End Bonuses Subject to Corporate ProfitabilityCompany DescriptionBRUNS-PAK is a New Jersey based data center engineering firm that helps clients strategize, implement, and provision innovative, resilient solutions for mission-critical data center infrastructure. In an always-on world flooded by data and demanding information connectivity through an ever-expanding array of devices, we deliver robust design/build solutions for cloud, colo, datacenter, and edge environments. We engineer solutions that balance ultra-reliability with Quality of Service (QoS) demands, storage challenges, environmental responsibility, energy efficiency, capital expenditure (capex) control, and operational expenditure (OPEX) options. With a legacy of over 6,000 successful data center projects across the United States, Canada, and Europe, BRUNS-PAK’s engineering expertise spans cloud, colocation, on-premises, edge, and hybrid infrastructures.BRUNS-PAK is a New Jersey based data center engineering firm that helps clients strategize, implement, and provision innovative, resilient solutions for mission-critical data center infrastructure. In an always-on world flooded by data and demanding information connectivity through an ever-expanding array of devices, we deliver robust design/build solutions for cloud, colo, datacenter, and edge environments.\r\n\r\nWe engineer solutions that balance ultra-reliability with Quality of Service (QoS) demands, storage challenges, environmental responsibility, energy efficiency, capital expenditure (capex) control, and operational expenditure (OPEX) options. With a legacy of over 6,000 successful data center projects across the United States, Canada, and Europe, BRUNS-PAK’s engineering expertise spans cloud, colocation, on-premises, edge, and hybrid infrastructures.

By applying, you're joining our Management Consultant talent network. About Mercor’s talent network Join our Management Consultant Expert Network to connect with leading AI labs and companies seeking your expertise. About Mercor projects Experts in our network contribute to: - Training and eva

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