Match score not available

Senior Regulatory and Start-Up Specialist (m/f/d) - North America

Remote:

Full Remote

Salary:

77 - 77K yearly

Experience:

Senior (5-10 years)

Work from:

Massachusetts (USA), North America, United States

Offer summary

Qualifications:

University degree in Medicine, Pharmacy or Life Sciences, At least 4 years of regulatory and start-up experience, Comprehensive understanding of drug development process, Knowledge of local regulatory requirements and GCP.

Key responsabilities:

Oversee IRB submissions for clinical trials
Negotiate and manage site contracts and budgets
Develop country-level study submission strategies
Act as primary contact for clients during start-up phase

Optimapharm http://www.optimapharm.eu

501 - 1000 Employees

See all jobs

Job description

📌Location: home-based

Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients’ lives.

Optimapharm’ s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.

With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators in all countries in Europe and North America. Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.

We are seeking an accomplished Senior Regulatory and Start-Up Specialist (Sr RSUS) to join our expanding team in US. If you are a detail-oriented professional with a deep understanding of regulatory submissions and site startup strategies, and you thrive on driving clinical trial success, we want to hear from you!

🎁 What do we offer?

Working in a successful company that’s growing and developing every day
Company that supports life balance
Company with healthy culture
Working with a highly experienced team of clinical research professionals
Competitive salary
Competitive PTO entitlement
Health insurance, including vision and dental plans, to meet your and your family's needs
Comprehensive pension plan to maximize savings and prepare confidently for the future
Employee engagement programs
Well-being initiatives
Training and development program
Fast-paced career path progression

🔎 Who are we looking for?

💼 Qualifications And Experience

University degree in Medicine, Pharmacy, Life Sciences, or equivalent combination of education, training, and experience
At least 4 years of experience in regulatory and start-up activities with proven expertise and strong knowledge of Ethics, including central IRB submissions, Site Contract & Budget negotiations, and Safety reporting requirements
Comprehensive understanding of the drug development process, GCP, ICH Guidelines, ISO 14155, and relevant IRB clinical investigation guidelines
Knowledge of local regulatory requirements/guidelines/ personal data privacy laws and international industry standards (GCP ICH and CFR FDA Regulations)
Experience in clinical research within CROs and/or BioPharmaceutical settings, including site contracts & budget negotiation, and team collaboration
Proficiency in computer systems (e.g., Excel), technical problem-solving, and the ability to manage abstract and complex variables
Strong written, oral, administrative, and presentation skills; ability to communicate effectively with internal and external stakeholders
Skilled in time management, multitasking, and working independently in fast-paced, team-oriented environments
Affinity for mentoring and supervising, with a proactive, diplomatic, and reliable approach
Strong problem-solving, negotiation, and customer service skills, with a focus on building relationships and achieving results

📑 Your responsibilities

Oversee & support the sites with IRB submissions for clinical trials in compliance with applicable laws, regulations, and guidelines, including SOPs, GCP, ISO 14155, and FDA/IRB guidelines.
Negotiate, manage, and administer site contracts and budgets, including agreements with institutions, principal investigators, study site staff, and external facilities involved in study conduct.
Prepare and implement country-level study submission and site startup strategies.
Provide input on project plans, documents, and guidelines.
Act as the primary Client/Project contact for assigned countries/sites during the start-up phase.
Serve as a point of contact for country-specific regulations and processes.
Mentor newcomers and train team members on country-specific SOPs, work instructions, and submission processes.
Develop training presentations and participate in the creation of SOPs/WIs.
Prepare and review essential documents required for Investigational Medicinal Product or Device release to investigational sites.
Manage submissions of periodic or local safety reports to ethics committees and regulatory authorities in compliance with relevant laws and regulations.

If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.