Medical Writer Salary at G & L Scientific Inc BETA

Job Summary: The Principal Medical Writer (MW) provides MW leadership and subject matter expertise to cross-functional project teams and drives the efficient development of study-level and program-level clinical regulatory documents. She or he is a strategic thinker and decision maker who effectively collaborates with internal and external stakeholders to coordinate document content, quickly resolve conflicts, and meet established timelines. Duties And Responsibilities Research, write, and edit complex clinical and cross-functional documents to advance and meet the regulatory requirements of development programs. Study-level documents include Phase 1-4 protocols and clinical study reports. Program-level documents include investigator brochures and other clinical IND modules, clinical summary and overview NDA modules, and responses to information requests for submission to worldwide health authorities in eCTD format. Contribute to the overall regulatory strategy for clinical development

Director - Clinical Pharmacology - Permanent - Jersey, USA (Remote) Proclinical is seeking an experienced Clinical Pharmacologist to join an innovative biotech company, supporting one of their latest assets to hit the clinic. Primary Responsibilities: The successful candidate will provide strategic and scientific expertise, represent Clinical Pharmacology (CP) in a dynamic cross-functional clinical development team, and collaborate with both internal and external stakeholders to execute CP strategies. This position offers the unique opportunity to participate in the rapid growth of a biotech startup. Skills & Requirements: Advanced degree (PhD, PharmD, or MD) with training in CP, PKPD, Pharmacology, and Pharmaceutical Sciences. Experience in the application of CP within drug development in the healthcare industry. Expertise with monoclonal antibodies programs and TMDD modeling. Proficiency with PK, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE),

Job Title: Development Scientific Director Location: Cambridge, MA About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The clinical scientist is a responsible member of the clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The primary purpose of the Clinical Scientist's position is to support the Clinical Research Director (CRD) and/or clinical lead in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to key study documents and activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes. We are an innovative global healthcare com

HarveStaff is working with a global leader in agriculture enterprise to find a Medical Affairs Writer to support the department in coordinating medical training and compliance. They provide group support in medical writing and administration of research, partnerships, and HCPs (healthcare providers) contracts. Job Description Perform medical writing to support scientific publications, medical training programs, and conduct internal publication clearance for the US medical affairs department. Support the VP of US Medical Affairs on local medical governance-related activities such as compliance tracking, local standard operating procedure updates and roll out to meet compliance requirements. Support the coordination of medical inquires, medical or product research, and fellowship programs. Help set agenda and scheduling with goals to build capabilities and performance excellence and efficiency of the team. Oversee and administer all department contracts and purchase orders including thos

The team is seeking a hardworking, results-focused Document Facilitator who will assist in the formatting, facilitation, and document approval process through GMP documentation systems. The position will work with analytical scientists in the delivery of complete and thorough analytical work packages to support clinical Biologic drug substances and drug products. This position will report directly to a Senior Manager within the Sample and Data Management (SDM) Group of the Analytical Strategy & Operations (ASO)-GxP Biologics department. Essential Duties and Responsibilities include, but are not limited to, the following: Edit and format GMP documents including Specifications, SOPs, and Technical Documents. Facilitate the routing of technical documents through required workflows. Review documents for grammatical errors and formatting. Work with several technical teams and collaborators at BMS Biologics manufacturing sites, including Analytical testing, Process Development, and Materials

We are Area 23 on Hudson. We don’t just make great work; we specialize in building work that meaningfully changes behavior. If you are a medical professional with a passion for scientific and clinical excellence and thrive in dynamic environments where your expertise can drive brand success and strategic growth, we have an exciting opportunity for you to join our team as a Medical Director. The Role As a Medical Director, you will assume responsibility for understanding the scientific and clinical aspects of your assigned brands in depth. You will serve as a key strategic resource for both internal teams and clients, leveraging science in brand differentiation and communications. Collaborating with copywriters and medical writers, you will ensure scientific and clinical relevance throughout strategic and creative development. Key Responsibilities Develop a deep understanding of assigned products, related medical areas, and competitors. Critically review content developed by agency team

We are Area 23 on Hudson. We don’t just make great work; we specialize in building work that meaningfully changes behavior. If you are a medical professional with a passion for scientific and clinical excellence and thrive in dynamic environments where your expertise can drive brand success and strategic growth, we have an exciting opportunity for you to join our team as a Medical Director. The Role As a Senior Medical Director, you will assume responsibility for understanding the scientific and clinical aspects of your assigned brands in depth. You will serve as a key strategic resource for both internal teams and clients, leveraging science in brand differentiation and communications. Collaborating with copywriters and medical writers, you will ensure scientific and clinical relevance throughout strategic and creative development. Key Responsibilities Develop a deep understanding of assigned products, related medical areas, and competitors. Critically review content developed by agen

Our client is looking to fill the role of Medical Writer. This role will be fully remote. 1 year duration / fully remote Responsibilities: Writing based role within the Global Regulatory Affairs group Responsible for accurately authoring various regulatory documents including (clinical study reports, IBs, protocols, briefing packages, annual reports, integrated data summary reports and submission modules) Will be supporting the writing and preparation of documents submitted to regulatory agencies globally Serve as medical writing expert supporting various therapeutic area project teams Effectively manage writing activities across a variety of assigned projects Ensure continuous alignment to medical affairs strategy Required Qualifications: Minimum of a BA/BS in Life Science; graduate degree preferred 4-7 years pharmaceutical/biotechnology experience (clinical research focus) Seeking BA/BS + 7 years of relevant experience or MS/PhD + 4 years of relevant experience Expertise in writing/d