Senior writer jobs in Westfield, New JerseyCreate job alerts

PRIMARY FUNCTION • Director/Senior Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects, • Serves as a team member supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, medical monitors, regulatory authorities, medical affairs, commercial, Key Opinion Leaders, Advisory Boards, • The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, drug-drug interactions, PBPK, PopPK modeling and E-R analysis. Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions MAJOR RESPONSIBILITIES AND DUTIES • Accountable and responsible for the Clinical Pharmacology support for the HUTCHMED global portfolio, • Provide scientific insights that drive global clinical development decisions and support global regulatory submissions, • Responsible for ensuring appropriate Clinical Pharmacology representation on drug/ dosage form development and clinical teams and provision of PK/PD expertise and leadership to a project, • The incumbent will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed, • Responsible for ensuring planning and direction of Clinical Pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting), • Responsible for ensuring leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies, • Responsible (with members of Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses in first in human studies and dosage regimens in patients, • Responsible for summarizing and interpreting results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs, • During the pre-clinical stages of drug development, works with Drug Discovery team to ensure that sufficient preclinical PK/PD knowledge exists to support progression into first in man studies, • Accountable for ensuring that there are valid methods for measuring drug and metabolite concentrations (or any biochemical biomarkers) in human studies, • Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the Clinical Pharmacology study, • Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assist with internal and external dissemination of results to Development Team, Investigators etc., • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the Clinical and Development teams and in regulatory documentation such as labeling, • Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design, • Participates in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management, • Acts as technical lead for specific development projects, Phase I/III and Clinical Pharmacology centric studies, • Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders MINIMUM REQUIREMENTS • PhD in clinical pharmacology, quantitative pharmacology, pharmacokinetics, or related field / MD/ PharmD preferred, • Biologics including monoclonal antibody, bispecific antibody, and antibody-drug conjugate experience is preferred, • Experiences in Oncology/Autoimmune disease field is preferred, • Proven expertise in pharmaceutical/biotech industry (8-15 years) with adequate knowledge in ICH guidelines, Good Clinical Practice applicable to Clinical Pharmacology, • Direct experience with clinical pharmacology summary documents required for Regulatory submissions, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization, • Experience in clinical development and new drug registration, • Mastery of statistics applied to clinical research, • Ability to work with pharmacometrician for PopPK modeling, E-R analysis, PBPK, and PK-PD modeling, and interpret the data to support the clinical development, • Good ability to interpret complex clinical data and experimental results, • Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy, • Self-motivated and self-disciplined individual with superb problem-solving and leadership skills, • Excellent English (writing and speaking) and excellent mastery of English medical terminology PREFERRED SKILLS AND EXPERIENCE: • Knowledge of FDA, EMA and ICH guidelines and regulations, • Record of successful publications in the area of clinical pharmacology/pharmacometrics, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required, • Candidate must demonstrate thorough understanding of principles of clinical pharmacology including clinical study design, analysis, and interpretation, and application of these approaches to drug development, guidelines in the design of clinical trials and development plans KEY COMPETENCIES: • Ability to organize and work simultaneously on multiple projects, • Ability to work in a matrix, project-oriented environment, • Excellent written and oral communication skills, interpersonal/influencing skills, and ability to work in a continually changing environment, • Supports the success of a group being led by providing clarity, support and tools needed to excel as things change, • Maintains a functional, perspective and acts on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the organization, • Actively builds relationships and networks with others across and beyond HUTCHMED working constructively across organizational boundaries despite differences in interests, perspectives and need

Job Description ABOUT ORGANOX: OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. Position Summary The position of Senior Process Engineer will work in the US Operations Department and is responsible for US Supply Chain, Operations and Logistics activities by working on the Continuous Improvement Projects that are identified. This will be achieved by designing, documenting, implementing and optimizing departmental processes used for operations, logistics and inventory management. The Senior Process Engineer has the following key areas of responsibility: • Design, analyze and implement operational workflows across US operations and supply chain., • Identify opportunities for process improvements and participate in continuous improvement initiatives., • Develop and maintain technical process documentation, including Standard Operating Procedures, Work Instructions and Process Maps., • Gather and report process metrics. Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the job holder will be expected to complete tasks reasonably requested by the Senior Manager, Operations. This is a flexible, on-site role in our Madison, NJ office. Major Responsibilities Under direction from the Senior Manager, Operations, the Senior Process Engineer will be responsible for: • Develop and maintain procedures that ensure compliance to ISO13485 for Operations Projects that fall under the scope of the OrganOx Quality Management System (QMS)., • Create and review Specifications, Standard Operating Procedures and Work Instructions., • Work closely with the Regulatory Affairs and Quality departments to ensure compliance with relevant medical device regulations., • Create and review Change Controls (CCs), Risk Assessments (RAs), Root Cause Analysis investigations, Supplier Corrective Action Reports (SCARs), Nonconformance Reports (NCs), Corrective and Preventive Actions (CAPAs) and other internal & external documentation needed to support US Operations., • Work collaboratively with colleagues at all levels in all departments to improve current processes and develop a culture of continuous improvement., • Participate in the execution of US Operations Projects and work with cross functional teams to ensure successful execution., • Support implementation of continuous improvement opportunities throughout the scope of operation for OrganOx Inc with the objective of improving Safety, Quality, Delivery performance and Cost., • Collect and analyze process data and recommend improvements. Skills & Experience • A hands-on approach to developing, evaluating, and improving processes., • The ability to evaluate, explain and simplify complex issues., • Proven strong knowledge and understanding of process principles and engineering techniques., • Previous experience in writing clear and concise Work Instructions, Standard Operation Procedures and other relevant Quality Documentation; acting as a Quality Technical writer., • Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English., • Experience with validation protocols (IQ/OQ/PQ), FMEA, and control plans., • Proficiency in project management tools (e.g, MS Project, Smartsheet, or equivalent)., • Strong and concise communication skills, both verbal and written., • Ability to work effectively with outside suppliers and manufacturers., • Self-motivated and driven to succeed., • Very strong collaborative skills., • Ability to work across a wide range of projects simultaneously., • Ability to work well in teams., • Willing and able to travel globally. (Up to 10%). Requirements • A hands-on approach to developing, evaluating, and improving processes., • The ability to evaluate, explain and simplify complex issues., • Proven strong knowledge and understanding of process principles and engineering techniques., • Previous experience in writing clear and concise Work Instructions, Standard Operation Procedures and other relevant Quality Documentation; acting as a Quality Technical writer., • Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English., • Experience with validation protocols (IQ/OQ/PQ), FMEA, and control plans., • Proficiency in project management tools (e.g, MS Project, Smartsheet, or equivalent)., • Strong and concise communication skills, both verbal and written., • Ability to work effectively with outside suppliers and manufacturers., • Self-motivated and driven to succeed., • Very strong collaborative skills., • Ability to work across a wide range of projects simultaneously., • Ability to work well in teams., • Willing and able to travel globally. (Up to 10%). Qualifications • Bachelor’s Degree in Process, Manufacturing, Biomedical, Industrial and Systems Engineering or related field required; master’s degree preferred., • Minimum 7 years of experience in process development, design and process implementation required., • Strong Project Management skills., • Previous experience in supply chain and operations preferred., • Experience in the medical device industry preferred., • Good working knowledge of the Safety, Quality and Regulatory Standards (ISO 14971, IEC 60601, ISO 13485 etc.) required., • Good working knowledge or qualifications in improvement methodologies such as Lean or Six Sigma (Green Belt preferred)., • Good working knowledge or qualifications in process Design & Review (DFx) preferred., • Ability to travel up to 10% of the time domestically and globally. Benefits We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Revision