- Kelly Services (Oklahoma City, OK)
- …meet current GMP, regulatory, and quality standards. + Act as the lead writer for technical transfer projects, ensuring accurate and comprehensive documentation ... **Tech** **nical** ** Writer (GMP)** **Batch Record Review & Deviation Investigation**...The ideal candidate will have a strong background in technical writing, deviation management, and experience within pharmaceutical… more
- Actalent (Shirley, NY)
- SEEKING A STRONG TECHNICAL WRITER FOR A CONTRACT ROLE We are seeking a detail-oriented and skilled Technical Writer to join our team for a key project ... Communication, Life Sciences, or a related field. + Previous experience in technical writing, preferably within the pharmaceutical or biotechnology industries. +… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …strengthens health systems at local, regional, and global levels to deliver end-to-end pharmaceutical services. The Senior Proposal Writer Manager will serve as ... disabilities. Brief Job Overview USP seeks a Senior Proposal Writer Manager to serve as a key member of...capability statements and other stock language describing USP's core technical areas (eg, local pharmaceutical manufacturing; medicines… more
- Abbott (Santa Clara, CA)
- …to detail with accountability for ensuring deliverables are met on time. + Technical writing experience in the medical or pharmaceutical , clinical research, ... fingersticks. **The Opportunity** The function of a **Senior Medical Writer /Project Manager** supporting our Vascular Clinical Evaluation Products combines… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Facilities Compliance Specialist ( Technical Writer ) position. Regeneron successfully manufactures a range of ... regulatory audits. **This role might be for you if you:** + Have technical writing experience in a manufacturing environment, pharmaceutical industry preferred +… more
- Takeda Pharmaceuticals (Columbus, OH)
- …life-changing therapies to patients worldwide. Join Takeda as a Principal Medical Writer where you will working across therapeutic areas to provide expert support ... + Reporting to a Medical Writing Team Lead, the Principal Medical Writer guides medical writing activities for key clinical and regulatory documents and… more
- J&J Family of Companies (Spring House, PA)
- Nonclinical Submissions Writer , Preclinical Sciences and Translational Safety - 2406219580W **Description** Johnson & Johnson is recruiting for Nonclinical ... Submissions Writer , Preclinical Sciences and Translational Safety to join our...submission ready components and to facilitate the completion and technical /scientific correctness of SEND data + To assure the… more
- ManpowerGroup (Cambridge, MA)
- ** Pharmaceutical Deviation and Investigations Writer ** Our client in **Cambridge, MA, Kendall Square** is looking for hardworking, motivated talent to join their ... (multiple shifts available )** **Job Description:** The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning… more
- ThermoFisher Scientific (Mount Prospect, IL)
- …or equivalent experience. + Minimum of 5 years in a cGMP environment within the pharmaceutical , food, or cosmetic industry. + Minimum of 3 years of experience in ... technical or scientific writing principles. + Demonstrable knowledge of...well as the Production and Warehouse environments in a pharmaceutical facility. This role routinely uses standard office equipment… more
- Catalent Pharma Solutions (Madison, WI)
- **Position Summary** **Associate Lead I - Biomanufacturing, Technical Writing** Catalent is a global, high-growth, public company and a leading partner for the ... pharmaceutical industry in the development and manufacturing of new...and client requirements. The Associate Lead I - Biomanufacturing, Technical Writing under minimal supervision, authors and revises deviation… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …check prior to submission. + Provides ad hoc research, and in coordination with technical and other proposal team leads as required. + Mentors junior staff on ... standards and managing compliant and responsive proposals. + Engage with staff technical experts to become familiar with the subject matter. + Research, monitor,… more
- Merck (North Wales, PA)
- …scientist on the clinical trial team. + Collaborates with the Medical Writer on clinical/scientific and regulatory documents. + Partners with Study Manager on ... conflict resolution, and critical thinking skills + Advanced communication, technical writing, and presentation skills **Position Qualifications** **:** **Education… more
- Pfizer (Pearl River, NY)
- …and specialized problems related to clinical research programs. + Applies technical /scientific expertise to resolve problems regarding the clinical components of ... documents (ie, Investigational New Drugs, New Drug Applications/Common Technical Documents, global registration dossiers, lifecycle strategy documents, internal… more
- Takeda Pharmaceuticals (Columbus, OH)
- …to queries (RTQs), various annual reports (DSUR, DSUR, PBRER) and nonclinical technical reports for drug products across Takeda's R&D portfolio (preclinical through ... 10 years of leadership experience with nonclinical regulatory writing within a pharmaceutical company or Contract Research Organization (CRO) + Experience in … more
- AbbVie (North Chicago, IL)
- …all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic ... + Effectively function as a senior research scientist, generating original technical ideas and research or development strategies. + Demonstrate the ability… more
- Lilly (Philadelphia, PA)
- …manufacturing and analytical procedures and method validations + Review technical documents including testing protocols, technical reports, and ... Degree, or Master's degree, or PharmD. + Experience in pharmaceutical development and/or manufacturing with 5+ years of CMC...of CMC regulatory experience or related experience (eg CMC writer ). + Qualified applicants must be authorized to work… more
- Insight Global (Boston, MA)
- …management experience, comfortable managing multiple stakeholder relationships . Strong technical writer with previous experience authoring, reviewing and ... Seaport district of Boston supporting one of our top pharmaceutical clients. This is a first shift role, on-site...through Friday. This position will be supporting the growing technical services team in their risk assessment efforts. This… more
- J&J Family of Companies (Columbus, OH)
- …The Director, Regulatory Medical Writing (RegMW) is a highly experienced medical writer and influential leader with strategic responsibilities as it relates to the ... (Masters, PhD, MD) preferred. + A minimum of 12 years of relevant pharmaceutical /scientific experience is required. + A minimum of 10 years of relevant medical… more
- Pfizer (Pearl River, NY)
- …requirements, clinical plan expectations, and study timelines; this includes ensuring medical/ technical requirements for data integrity are applied. + Works with ... statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and… more