Senior Medical Writer - Regulatory & Clinical Submissions
Staffingagencyrecruitment
Staffingagencyrecruitment is seeking a skilled Medical Writer in Paramus, NJ, with 3-5 years of experience in medical writing for the pharmaceutical industry. The role involves preparing regulatory documents and collaborating with clinical teams to ensure compliance with industry standards. The ideal candidate holds an advanced degree in Life Sciences and possesses excellent scientific writing skills. A proactive attitude and ability to multitask in a fast-paced environment are essential. Offers a chance to work on diverse projects in a dynamic setting. #J-18808-Ljbffr
- ...experienced Biostatistics leader in Paramus, NJ to support clinical development programs across various phases. The ideal candidate... ...include leading statistical activities, supporting regulatory submissions, and ensuring quality statistical deliverables. Strong SAS...SeniorRegulatory
- ...Senior Director, Clinical Development - Oncology - SK Life Science Labs... ...-1934 Category Medical Affairs Type Regular... ...preclinical, translational, CMC, regulatory, and clinical operations... ...programs and regulatory submissions as needed Oversee...SeniorRegulatoryFull time
- ...Experience level: Mid-senior Experience required: 5 Years Education... ...POSITION We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with... ...documents for clinical trials and submissions. Epilepsy or Neurology...RegulatoryWork at officeVisa sponsorshipRelocation packageShift work
- ...This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company's compliance... ...Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance Must Have:...SeniorRegulatory3 days per week
$80k - $100k
...specific health and lifestyle goals. Role The Senior Operations Manager plays a critical role... ...and strategic initiatives of the clinic. This position requires strong leadership... ...and protocols to ensure compliance with regulatory requirements, quality standards, and best...SeniorRegulatory- A leading medical technology firm based in Franklin Lakes, NJ, seeks a Clinical Database Programmer 2 for a 5-month contract. The successful candidate will lead... ...and experience with clinical data for regulatory submissions are required. Candidates must be US citizens...SeniorRegulatoryContract work
$300k
...Senior Vice President, Clinical Development Oncology (Remote)United StatesWe are... ...development strategies, leading regulatory interactions, and driving... ...in support of regulatory submissions, including clinical... ...externallyAct as primary Medical Monitor, monitoring the safety...SeniorRegulatoryRemote work- ...Integrated Resources, Inc ( IRI ) is seeking a Medical Writer based in Nutley, New Jersey. The successful candidate will hold a Bachelor... ...compliance with ICH, GCP standards, and quality control review in clinical development documentation. Proficiency in MS Word and Excel...Regulatory
- ...of working with multiple disciplines in clinical development in the pharmaceutical industry... ...compliance standards, and ICH, GCP, and regulatory requirements. Proven writing, editing,... ...years pharma/biotech experiences. Previous medical writing experiences preferred. #J-18808-...Regulatory
- ...experienced Biostatistics leader to support clinical development programs from protocol design through final study reporting, regulatory submissions, and post-study analysis . This role... ...clinical, regulatory, data management, medical writing, and external vendor teams...SeniorRegulatoryContract work
$139.1k - $231.9k
...data integrity and quality of clinical trial(s) in support of the... ...partner with other clinical and medical colleagues, clinical... ...in governance meetings and submissions, partners with/supports the... ...materials, clinical study reports, regulatory responses, and other...SeniorRegulatoryPermanent employmentH1bWork at officeLocal areaVisa sponsorshipWork visaRelocation package2 days per week- The Senior Trauma Clinical Data Coordinator is responsible for the oversight of the data management... ...Department of Trauma at Hackensack University Medical Center (HUMC). This includes, but is... ...report form completion and research regulatory reporting. Education on human subject...SeniorRegulatoryFull timeWork at office
- ...Job Title – Senior Clinical Data Manager Location - Franklin Lakes, NJ Duration – 6+... ...hours: 8am-5pm, 40 hours/week Client: Medical Device Company Employment Type: Contract... ...clinical research process and regulatory requirements. Able to acquire and apply...SeniorRegulatoryContract workLocal areaRemote work
- ...to spearhead statistical programming activities for multiple clinical studies. The ideal candidate will leverage their expertise to... ...Alzheimer’s disease and neurology research. A strong grasp of CDISC standards and regulatory requirements is essential. #J-18808-Ljbffr...Regulatory
- ...Summary of Position: The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report... ...statistical activities in drug in-licensing, regulatory filings and marketing. Duties...SeniorRegulatory
- ...Job Description GCP Senior Auditor Paramus, NJ (Hybrid)ContractMid-Senior Level... ...Assurance programs across global clinical development and safety operations. This... ...a key role in ensuring compliance with regulatory requirements, internal SOPs, and quality...SeniorRegulatory
$84k - $112k
...Princeton10 is seeking a Senior Medical Editor to ensure editorial quality and regulatory compliance. This position allows remote work from the United States or Canada, preferring candidates in Eastern time zones. The role involves reviewing and editing promotional...SeniorRegulatoryRemote work- A biopharmaceutical company is seeking a Clinical Supplies Manager to oversee and support key operations related to clinical supplies... ...include managing clinical supply inventories, supporting regulatory submissions, and collaborating with various departments to ensure...Regulatory
- ...Improvement, Education & OASIS Coordinator (RN) to enhance quality and regulatory compliance in home care. This role includes leading performance initiatives, ensuring OASIS accuracy, and educating clinical staff. The ideal candidate will have at least 5 years of experience...SeniorRegulatoryWork at office
- ...Hackensack Meridian Health Inc. seeks a Clinical Research Coordinator in Paramus, NJ. This role is responsible for overseeing clinical... ...demonstrate proficiency with Microsoft Office and Google Suite, ensuring compliance with all regulatory guidelines. #J-18808-Ljbffr...RegulatoryWork at office
- ...This position is responsible for supporting the phase 3 clinical trial , including but not limited to, as outlined below... ...CSRs and performs data interpretation. Supports submission strategy planning, regulatory communication and development of Health Authorities responses...SeniorRegulatory
- ...Overview The Director of Clinical Development CNS will be involved... ...The Director will work with regulatory, discovery, business... ...position will report to the Chief Medical Officer of SK Life Science.... ...programs, regulatory submissions, and GCP inspections when necessary...Regulatory
- ...Clinical Supplies Manager Paramus, New Jersey, United States About the Job SUMMARY OF POSITION... ...project financial tracking. Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global). Assist and support the...RegulatoryContract workWork at office
- ...Job Description The Physician Advisor (PA) is a clinical leader responsible for ensuring appropriate patient care, optimizing resource utilization, and maintaining regulatory compliance. The PA conducts medical necessity and utilization reviews, manages denials and...Regulatory
$200k - $225k
...Veolia is seeking a Senior Director of General Accounting to lead their accounting functions in Paramus, NJ. This key leadership role involves overseeing general accounting and regulatory compliance while driving improvements in accounting processes. The ideal candidate...SeniorRegulatory- ...Overview The Senior Director, Medical Affairs Insights & Field Operations, is responsible for supporting... ...stakeholders, Collaborate with Clinical Development & Operations to support the... ...pipeline assets, Partner with Legal, Regulatory and other cross-functional teams to...SeniorRegulatory
$80k - $140k
...by Dr. Meir Olcha, our Medical Director and a double board... ...We are seeking a Senior Embryologist to join our clinical embryology team. In this... ...and applicable New Jersey regulatory standards. Maintain accurate... ...and support SART data submission. Collaboration & Mentorship...SeniorRegulatoryWeekend workAfternoon shift$154.3k - $204.3k
...including benefit/risk and regulatory activities and interactions.... ...contribute to key scientific/clinical discussionsApply effective communication... ..., IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, CSRs (incl... ...sections of regulatory submissions, e.g., IND/CTA(General...SeniorRegulatoryHourly payLocal area- ...This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance... ...position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs...SeniorRegulatory
$39.33 per hour
...Health System (New Jersey) is looking for a Medical Technologist to independently process... ...laboratory findings according to strict regulatory standards. The ideal candidate will... ...certification and have at least 5 years of clinical laboratory experience. The position emphasizes...RegulatoryHourly pay
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