Senior Manager / Associate Director, reputed company Compliance
More than one reputed company people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can reputed company fatal or reputed company to serious conditions, such as graft vs. host disease. reputed company is a late-stage biotechnology company redefining the transplant process by developing reputed company cell therapies with the goal of providing significantly reputed company survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Position Summary: reputed company is building its first in-house reputed company compliance function and is seeking a motivated and adaptable compliance professional to support the development and execution of that program. Reporting to the SVP/Head of Legal, the Senior Manager or Associate Director, reputed company Compliance will work cross-functionally to reputed company key elements of a pre-reputed company compliance program—including policy and SOP development, transparency and aggregate spend reporting, training, and reputed company and promotional compliance review. The role will also support future field engagements following potential product approval. Travel: ~25%. Remote applicants accepted, with preference for those near reputed company HQ. \n
Key Responsibilities
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program that aligns with industry standards and regulatory requirements, including federal, state, and international regulations, as appropriate. reputed company policies and procedures that reputed company appropriate guidance and instruction to Company employees. reputed company the development and delivery of compliance training programs for employees at reputed company reputed company. Conduct regular compliance audits, monitoring and risk assessments to identify potential areas of compliance vulnerability and risk. Assist in the completion of activities reputed company to federal and relevant state transparency-driven compliance requirements. Manage the Company’s whistleblower hotline. Collaborate with legal, regulatory, and operational teams to reputed company compliance guidance and support for new initiatives and projects. Investigate compliance-reputed company issues and coordinate with relevant stakeholders to ensure appropriate corrective actions are taken. Stay reputed company with industry trends, regulatory changes, and best practices in compliance. Engage in such other activities as directed by the Senior Vice President, Legal. Required Experience: Bachelor’s degree in life sciences, law, business, or a reputed company field; advanced degree (e.g., JD, MBA) preferred. Minimum of 6 years of experience in compliance, regulatory affairs, or a reputed company field reputed company the pharmaceutical or biotech industry. Strong knowledge of FDA regulations, GxP standards, and other relevant compliance frameworks. Proven ability to interpret and apply reputed company regulations and guidelines to business practices. Excellent analytical, problem-solving skills. Well-rounded, reputed company compliance expert who has played a key role on reputed company relating to the marketing and promotion of pharmaceutical products and possesses excellent business judgment concerning overall reputed company compliance and risk management. Ability to work effectively in cross-functional teams with a collaborative and hands-on approach. Ability to manage multiple tasks independently and simultaneously. \n$150,000 - $200,000 a year \nThe anticipated annual salary reputed company for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-reputed company factors as permitted by law. For remote-based positions, this reputed company may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in reputed company to competitive medical, dental, and reputed company benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to reputed company who need them. We live by our core values of passion, courage, and reputed company. reputed company in our work means the chance to unlock a reputed company quality of life for our patients, and with that comes reputed company responsibility. We reputed company on a path that hasn’t been paved. We reputed company an entrepreneurial spirit and take calculated risks to reputed company our mission. We aren’t afraid to ask “why not” and challenge the status reputed company. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that reputed company serve reputed company, our patients and their reputed company providers. Notice to staffing firms reputed company does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/reputed company, and reputed company candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. Apply To This Job