Our client, in the biotechnology industry, is seeking a contract Director/Senior Director Medical Writer. The Dir/Sr Director will focus on the preparation, assembly, writing, and review of the analyses and documentation needed in support of clinical studies and corresponding submissions to regulatory authorities including IND and NDA filings. He or she will be responsible for reviewing externally...

Our client is seeking a remote, Senior/Consultant, Regulatory Labeling. In this role, you will: • Collaborate with the client and their partners on an effective and efficient process for the global distribution and tracking of labeling updates for products • Disseminate and track approved labeling documents and supporting documentation for labeling compliance distribution and implementation...

Our client, in the biotechnology / life sciences industry, is seeking an Associate Director, Statistics (contract to hire). POSITION ACCOUNTABILITIES: • Serve as global statistical lead for biomarker development in Oncology Cell Therapy and TA. Provide statistical leadership and support for internal decision making, regulatory meetings, submissions, and follow-up. • Review key program...

Our client, in the biotechnology / life sciences industry, is seeking an Associate Director, Statistics, PRO and Benefit-Risk Assessment (contract to hire). The Associate Director is responsible for assisting the Director, Statistics with the management and leadership of biostatistics-related activities in the area of Patient-Reported Outcomes (PROs), other clinical outcome assessments, and...

Our client, in the biotechnology / life sciences industry, is seeking a Senior Manager, Statistics (contact to hire). The purpose of this position is to provide compound level/development phase statistical expertise and leadership by: • Independently designing, analyzing, and interpreting clinical or observational studies at a compound level for early phase or less complex programs. •...

Our client, in the biotechnology / life sciences industry, is seeking a GI Statistics, Senior Manager (contract to hire). POSITION OBJECTIVES: • Provide leadership at a compound level on clinical, regulatory, and commercial development strategies • Promote efficient innovative methodologies and optimal development plan • Contribute to strategies for statistics related technologies,...

Our client is seeking a contract Quality Training Specialist. The Quality Training Specialist will have experience with the creation of training materials, applying instructional design techniques, delivering training, and working within a Learning Management System (LMS). The individual will be responsible for LMS administrative activities, working with subject matter experts in the development...

Our client, in the life science / biotechnology industry, is seeking a Director of Global Program Team Effectiveness. This role will lead a Global Program Leader (GPL) Development Program to strengthen the capabilities of GPLs against a shared profile of success. As part of the Center of Operational Performance Team, you will report to the Head and strategize, lead and deliver multi-disciplinary...

Our client is seeking a contract Senior Research Associate. This client has an excellent opportunity for a highly motivated biologist with a strong background in cell / molecular biology. The Senior Research Associate, Biology position is available currently as a contractor for 12 months with the possibility of renewal. We are seeking a highly motivated and interactive bench scientist to join...

Our client is seeking a contract, remote Senior Medical Writer. The Senior Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of...

Our client, in the life science / biotechnology industry, is seeking a contract, remote Director of Regulatory Affairs. As Director of Regulatory Affairs, you will lead in the design, implementation, and execution of regulatory strategies and processes to obtain and maintain market authorizations that allow the company to legally market our IVD medical products internationally. You will build,...

Exciting opportunity to help shape the data engineering function and grow a team. This role is brand new for our client, in the life science /biotechnology industry, who is shifting to an in-house model and will be looking for a proven leader to frame out the data engineering function. They looking for someone with primarily large pharma experience who will be able to navigate the complex...

Our client, in the biotechnology industry, is seeking a Senior Project Manager. This position requires a Bachelor’s degree and a minimum of 5 years of experience in strong project and account management preferably in the pharmaceutical-related industry. The candidate must possess the following: • Strong project management experience • Strong client account management experience •...

The Director, Precision and Translational Program Management assumes the role as the lead on translational program management, accountable for both the leadership of the overall team and as needed, aspects of a translational program. You will use translational knowledge and expertise of the applicant to help develop the translational program management function and streamlined execution across the...

Our client is seeking a Principal Medical Writer for a remote, 6-12 month contact. This role independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of...

Our client is seeking a contract and remote Regulatory Affairs, Senior Associate/Manager.  The primary responsibility of the Regulatory Affairs Associate/ Specialist/Associate Director is to work under supervision to assist in planning, review, and preparation of investigational new drugs (INDs), new drug applications (NDAs), Biologic License Applications (BLAs), and all related annual reports,...

Our client, in the Life Science / Biotechnology industry, is seeking a Senior Regulatory Specialist. This role will provide direct support to the preparation and submission of IVD device authorizations to regulatory agencies including US FDA, Health Canada, Notified Body, Authorized Representative, and others. Core Job Responsibilities • Support Lead Regulatory Authors to prepare and author...

Precision Life Sciences is seeking a remote Senior Statistical Programming for our client in the Life Science / Biotechnology industry. This role will study teams, report study status to Statistical Programming management, and perform, or oversee the performance of all statistical programming-related activities while ensuring the integrity of the data and analysis by adhering to all applicable...

The Senior Clinical Research Associate (SCRA) will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. Primary Duties: • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial • Performs clinical study site management/monitoring...

Precision Life Sciences is working with a life science / biotechnology client in the Greater Miami area in Florida, that is seeking a contract Research Associate- Biochem/Biophysics. This role will be an important member of the Research team, responsible for maintaining, differentiating, and evaluating small molecules in patient-derived iPSCs, and differentiated cardiomyocytes and neurons. This...

Our client is seeking a contract Clinical Affairs Specialist. Reporting to the VP of Clinical, the Specialist is responsible for providing administrative and project support to facilitate the management of pre-approval and post-approval clinical trial processes for US-based clinical sites. The position supports all activities of study management from start-up to closeout including IRB interactions...

Our client is seeking a contract Research Scientist. The client has an excellent opportunity for a highly talented biologist with a strong background in cell / molecular biology. The scientist level position is currently as a contract research scientist for 12 months with the possibility of renewal. We are seeking a highly motivated and interactive bench scientist to join our team focused on...

Precision Life Sciences is seeking a contract, Quality Assurance Documentation Specialist for our client in the life science / biotechnology industry. This position will be responsible for partnering with cross-functional team members to ensure compliance with GxP documentation. The QA Documentation Specialist must have experience in authoring, editing, reviewing, evaluating, and maintaining...

Precision Life Sciences is working with a life science / biotechnology client in New Jersey that is seeking a contract Project Manager. This role owns the responsibility of managing a portfolio of complex interrelated proprietary products projects and programs from initiation, steering, and support towards successful execution and delivery of effective solutions that meet business needs. Main...

Precision Life Sciences is currently working with multiple clients seeking contract Clinical Research Associates.  These CRA roles offer the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes...

Precision Life Sciences is seeking a contract Scientist/Sr. Scientist Protein Biophysics for our client in the biotechnology / life sciences industry.  This role will lead the biophysical characterization and protein analytics efforts in developing new and novel molecules for therapeutic applications. The successful candidate will provide guidance and data-driven support for the nomination of drug...

Our client, in the biotechnology and life sciences industry, is seeking a contract Senior Lead Clinical Programmer to manage and support project deliverables and timelines. Responsibilities include designing, writing, validating, and maintaining software to meet specifications. In addition, specifies, develops, and validates applications supporting data capture and processing. First level...

Precision Life Sciences is working with a client, in the biotechnology / life science industry, to fill a contract Product QA Specialist role. The position will be responsible for the review and approval of GMP clinical and commercial pharmaceutical batch production records while maintaining relationships with external manufacturers to drive continuous improvement to their related quality systems...

Precision Life Sciences is working with a client, in the life science / biotechnology industry, to fill a contract Associate Director, Program Management role. Accountabilities and Responsibilities: • Facilitate defining and setting overall strategic program scope, and deliverables • Partner with the Research and Discovery functions to integrate activities across multiple programs. As...

Our client is seeking a strong scientific and strategic leader to head the clinical flow cytometry efforts. The Head of Oncology and Cell Therapy Flow Cytometry is an exciting, new role within the growing Precision & Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) reporting to the Head of Clinical Biomarker Sciences and Operations. The individual recruited for...

Precision Healthcare is working with a client to hire an experienced Registered Nurse for a contract assignment in Brookline, Massachusetts. This assignment is part-time, and the ideal candidate will have at least 1-year experience in Behavioral Health/Psych/Addiction recovery and/or accepting candidates with Memory Care and Med-Surg backgrounds. This is an open unit that’s getting ready to expand...

Objectives • Provides global program management to global, cross-functional, cross-divisional teams to drive development and deliver results in early to late-phase pipeline or marketed assets. • The remit includes providing strategic direction and translating the cross-divisional, integrated Global Product Team (GPT) strategy into an efficiently executable plan; predicting and planning...

The Sr. Manager will serve a dual role between Strategic Pricing & Government Accounts. This person will support the Director of Market Access in the development, implementation, and analysis of Pricing and contracting strategies across all customer segments including Commercial, Medicare, Medicaid, VA/DOD & 340B. In addition, this person will assist in the development of all pricing strategies &...

Our client is seeking a Senior Director, Biostatistics for a 6-month remote contract. The Senior Director, Biostatistics is responsible for the successful operation of the Biostatistics department, overseeing the statistical aspects of projects and project teams through the management of department managers, internal staff, and interaction with Executive-level staff. They oversee the maintenance...

Key Purpose: The Regulatory Strategist plays a key role in providing expert consultation clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions. S/he will serve on project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create...

The Director, Research Project Management assumes the role as the lead on research project management, accountable for both the leadership of the overall team and management of multiple research projects in Discovery. The role will leverage scientific knowledge and project management expertise to support the development of the research project management function and streamlined execution across...

We are seeking an experienced contract Regulatory Generalist to join our client, in the biotechnology / life science, as a Senior Regulatory Affairs Associate or Regulatory Affairs Consultant.  This position will work closely with one large, dedicated client and Regulatory Specialist to provide operational support in the IND/NDA maintenance stage. The Sr. Associate / Consultant will provide...

Precision Life Sciences is seeking a contract Quality Assurance Specialist for our client in the biotechnology / life science industry, to provide Quality oversight for Manufacturing and Quality Operations.  This includes documentation review of executed Quality records. This candidate will also assist in the development, implementation, and maintenance of quality systems and other Quality...

Precision Life Sciences is working with various clients in the biotechnology / life science industry that is seeking contract and permanent Clinical Project Managers (all phases, all therapeutic areas, all remote) to join their clinical teams. This is an excellent opportunity for someone with strong organizational skills and the ability to work on a variety of tasks and projects simultaneously...

Our client, in the biotechnology / life science industry, is seeking a contract Clinical Trial Manager OR Clinical Operations Lead (COL) to serve as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). The position as defined by scope provides leadership, mentoring, and technical support to the Clinical Operations team to ensure the...

Our client in the biotechnology / life sciences industry is seeking a Director/Senior Director of Program Management to lead and organize program teams for the clinical-stage programs and for other programs in developmental stages. This role will plan and coordinate resources to attain program and corporate objectives and serve as the point of contact for all aspects related to their programs....

The Regulatory Project Manager will be responsible for Regulatory submissions, timeline development, and maintenance of the Regulatory communications archive. The individual will interface cross-functionally both within the company and externally with service providers/partners. Key Responsibilities: Manage the document content, preparation, approval, and submission of global Regulatory filings...

The Principal Regulatory Strategist independently provides expert consultation clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions. S/he will serve on project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create a strong...

Summary The Senior Auditor, Quality Assurance is responsible for the assessment of quality and compliance according to the company and/or Sponsor SOP’s and all relevant regulations and guidelines. Essential Functions • Host Sponsor audits at the company and assists FDA Inspections • Assure that issues from sponsor audits are promptly communicated to the appropriate team members, assist...

Precision Life Sciences is working with a client, in the life science / biotechnology industry, for a contract, remote Senior Principal Biostatistician. The position will provide oversight on clinical studies and provide statistical support on the development of in-house clinical studies and projects. The positional is responsible for designing, implementing, and reporting in a quality, timely and...

Precision Life Sciences is seeking a contract Regulatory Affairs Consultant / Senior Consultant - Labeling for our client in the life science / biotechnology industry. As a Senior/Consultant, Regulatory Labeling, you will: • Collaborate with the client and their partners on an effective and efficient process for the global distribution and tracking of labeling updates for products •...

Our client in the biotechnology / life science industry is seeking a contact Assistant Director Clinical Data Manager.  The role will be responsible for the development and management of Data Management processes, including developing Data Management Standard Operating Procedures (SOPs), preparing and defending study-specific fee estimates to clients, presenting Data Management capabilities to...

At Precision Healthcare we pride ourselves on providing exceptional, dedicated, professional Recruiters who will have your back as you search for your next position. Precision Healthcare is working with a client that is looking for a full-time Registered Nurse in Tewksbury, Massachusetts. This ideal candidate will have at least 1-year of experience in working with kids from ages 12 to 18 years on...

At Precision Healthcare we pride ourselves on providing exceptional, dedicated, professional Recruiters who will have your back as you search for your next position. Precision Healthcare is working with a client that needs a Registered Nurse for a 3-month contract assignment in North Kingston, Rhode Island. This assignment is full-time, and the ideal candidate will have at least 1 year of...