Policy Executive / Strategic Planner (Technical Writer)

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies with focus on America’s and the clinical, and non-clinical disciplines. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics. Requires ability to work strategically, both independently and in a team environment. The position will ideally be based in the Ascendis Pharma corporate offices in Palo Alto, CA or Princeton, NJ.   Key Responsibilities Responsible for strategic and operational regulatory input for cross functional (non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues. Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations. Provides regulatory information and guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure compliance and product expansion. Acts as the company representative with regulatory authorities covering America’s Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs. Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines. Maintains up-to-date knowledge of highly complex regulatory requirements and communicates changes in regulatory information to project teams. Work both independently and by supporting the regulatory project team Contribute to internal regulatory policies and procedures to achieve best practices and work processes. Requirements BS/BA Degree in a Scientific Discipline, Advanced Degree required. Minimum of 10 years overall regulatory experience and preferably including experience managing investigational and marketed products. Prior experience representing Regulatory Affairs on cross-functional teams is desirable. Must be capable of effectively leading teams in preparation of submissions. Experience working on international teams desirable. Experience working on international submission desirable. Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business. Must be capable of critically reviewing complex technical documents and influencing colleagues across functions. Experience with drug-device combination products preferred. Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing applications is a plus. Ability to travel up to 10-20% of the time domestically and internationally, since part of the Regulatory Affairs organization is located in Princeton, Palo Alto and Denmark. Salary Range - $225-240K/year A note to recruiters: We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.  If this occurs your ownership of these candidates will not be acknowledged. Benefits 401(k) plan with company match Medical, dental, and vision plans Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of Pet Insurance and Legal Insurance Employee Assistance Program Employee Discounts Professional Development Health Saving Account (HSA) Flexible Spending Accounts Various incentive compensation plans Accident, Critical Illness, and Hospital Indemnity Insurance   Mental Health resources Paid leave benefits for new parents

Must have superintendent experience in multifamily construction. Only Experienced Superintendent candidates will be considered.  Summary: This position is responsible for managing construction projects. The position is also responsible for managing job site employees, contractors, and vendors. The Project Superintendent is responsible for onsite decisions that impact the success of the project, job site safety, training, compliance, and use and maintenance of small and heavy equipment. Essential Job Duties and Responsibilities: • Assist Project Manager with preliminary distribution of plans, receiving of preliminary bids, preparing score for contract, and administration of subcontractors. • Responsible for day-to-day site management including all subordinates and their responsibilities, coordinating subcontractors and suppliers. • Ensure project timelines are met, which at times may include performing job site tasks such as, quality checks and inspections, training, scheduling materials, labor, testing, use of elevators, equipment and tool operation, and cranes. • Responsible for flow charts, scheduling, and noting potential delays in site logs. • Monitor site costs, prepares agreements prior to purchase, rental, or leasing any required equipment, etc. • Ensure project changes are communicated, and approved by Project Manager prior to agreement. • Responsible for job site safety, equipment safety, and that all OSHA guidelines are met. • Work within company polices including drug-free, harassment free workplace guidelines to ensure job site safety and OSHA compliance, and professional work environment. • Conduct jobsite meetings and prepare minutes for same. • Ensure issues with subcontractors, suppliers, inspectors, or utility companies are communicated in writing until resolution is reached. Knowledge, Skills and Abilities (KSAs): • Ability to step-in and assist subordinates to complete their work if necessary. • Working knowledge of Microsoft Suite (Excel, Outlook, Word) and some Timberline software • Ability to communicate effectively with all levels of staff, owners and vendors • Strength in prioritizing, organizing and executing tasks • Work independently with little supervision • Stay on task with multiple competing priorities • Work independently as well as part of a team • Ability to perform essential functions of the position with or without accommodation. • Must be prepared and be able to perform physical work, operate equipment and conduct inspections of work performed as needed. • Walking the site and the use of stairs frequently throughout the day is a necessity for the position. • Must be able to travel long distances in personally-owned vehicle on short notice to and from assigned job locations, valid drivers license required. Education and Experience: • High school diploma or equivalent • 5 years experience in multi-family apartment building • Previous work in an office environment with customer service skills • Valid Drivers License Essential Job Functions: • Ability to perform essential functions of the position with or without reasonable accommodation • Ability to drive between jobsites and use own or company vehicles and equipment to perform job functions • Physical ability to walk the entire job site and use stairs all day long • Ability to perform basic data entry, keyboarding, and mouse functions to complete job duties timely and efficiently • Ability to read and effectively communicate with fellow employees • Moderate physical activity, such as walking, carrying and lifting, up to 50 lbs. Physical Requirements: • This is a physically active position requiring walking, standing, sitting, driving • Ability to lift 50 pounds PLEASE APPLY VIA COMPANY WEBSITE: https://www.paycomonline.net/v4/ats/web.php/jobs/ViewJobDetails?job=392244&clientkey=6E84203BC37F8634618E0AD716DFF521

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