Website Sedia Biosciences Corporation
Plans and directs clinical research program including study development, preparation, execution, oversight, oversight; plans and directs company regulatory matters including development, submission and maintenance of regulatory submissions, company registrations, regulatory responses pertaining to inquiries and inspections, and collaboratively with Quality Assurance, compliance with applicable regulations. Duties are performed personally, through subordinates or in collaboration with other departments. Coordinates project priorities within the Clinical Trials and Regulatory group and provides oversight of key clinical trial and regulatory decisions. Ensures that all Clinical trials and testing all Regulatory actions comply with Design Controls, Good Laboratory Practices and Good Manufacturing Practices (including FDA QSRs, ISO13485, etc.) as appropriate.
FLSA Status: Exempt
Reports to: VP of R&D, CSO or CMO
Manages clinical research and development aspects of the company’s product development efforts and product improvement projects, in collaboration with the individual project manager within or outside the Regulatory/Clinical Affairs department.
Coordinates with Project Managers regulatory submissions and regulatory approvals.
Maintains Clinical Research Files and conducts clinical studies under Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP) according to applicable clinical regulations and guidance.
Takes actions needed to ensure Company’s regulatory status with all applicable regulatory agencies and oversees response to any regulatory actions, coordinating Company response.
Routinely interacts with other internal and external management functions (e.g. Quality, Ops/Mfg., Sales & Marketing, Finance, Engineering, R&D, CRO’s, CMO’s, Clinical Sites, Consultants, Contractors and Vendors.) Ensure Regulatory compliance for project team activities and output consistent with expectations of Quality System. Ensures team follows GCPs and GCLPs and complies with applicable regulations as appropriate.
Other duties as may be assigned by supervisor.
Responsible for the Regulatory and Clinical Affairs Department including organization development, direction, coordination and evaluation of activities within.
Carries out supervisory responsibilities in accordance with the department’s policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees and addressing complaints and resolving problems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
B.S. with 20+ years, M.S. with 15+ years; Biochem/Immunol/Microbiology/Biology/Genetics/or similar.
15+ years in medical device or pharma arena required, including minimum 10 years’ experience in medical device clinical trial development, execution and report, and/or medical device regulatory submission development, submission, agency prosecution and ongoing support.
Experience in GCPs, GCLPs and GMPs. Experience as primary project manager for all clinical and regulatory aspects of one or more product developments and launches.
Prior experience managing experienced clinical technical personnel, including preferably on and offsite clinical research associates, trial managers, internal and external clinical trial managers. Prior experience managing junior associates for regulatory affairs highly desirable.
For consideration, please apply with a resume and cover letter.
Submit your resume and cover letter as an attachment in either RTF, Word, or PDF format to firstname.lastname@example.org.
In the Subject Line of your email, enter: “Your last name, your first name, middle initial (middle initial optional), and Job Title (that you are applying for).” For example, “Smith, Mary, Lab Technician.” If you are applying for multiple positions, please submit separate emails for each position.
To apply for this job please visit www.sediabio.com.