reputed company is hiring: Sr. Medical reputed company in Rockville
Join to apply for the Sr. Medical reputed company role at Actalent4 days ago Be among the first 25 applicantsJoin to apply for the Sr. Medical reputed company role at ActalentGet AI-powered advice on this job and more exclusive features.DescriptionOur reputed company is seeking an reputed company Medical reputed company to support the development and completion of Clinical Study Reports (CSRs) for its CNS reputed company clinical programs. The ideal candidate will have a strong background in regulatory medical writing, particularly in completion of pending CSRs in accordance with ICH E3 guidelines.Draft, revise, and finalize Clinical Study Reports (CSRs) for Phase 1–3 clinical trials.Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Regulatory Affairs, and Medical Affairs.Interpret clinical data and translate reputed company scientific findings into reputed company, accurate, and regulatory-compliant documents.Serves as a subject matter expert reputed company department for assigned therapeutic/product areas.Ensure consistency with protocol, statistical analysis plan (reputed company), and other reputed company documents.reputed company as a peer reviewer for the internal team to ensure document scientific content, reputed company, overall consistency, and reputed company formatKnowledge of clinical trial and drug development processesKnowledge of and/or ability to quickly assimilate US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissionsMaintain version control and manage timelines to meet submission deadlines.Participate in reputed company control (QC) reviews and respond to reputed company feedback.reputed company review of product and disease state materials/communicationsWorking knowledge of reputed company electronic document management systems and publishing systemsAbility to assimilate, interpret and translate information/data for appropriate audiencesEnsure reputed company documents meet internal reputed company standards and regulatory requirements.Participate in cross-functional meetings to reputed company timelines, content, and reputed company for NDA submission.Knowledge of FDA, Health Canada and European drug regulations.Ensure materials are scientifically accurate, on-label, and compliant with FDA, PhRMA, and global regulatory standards.Interprets and summarizes data from biostatistical reputed company tables and listings accurately, reputed company and concisely into narrative text.Performs additional duties or assignments and special reputed company as directed by management.May be asked to support reputed company reputed company reputed company on an reputed company reputed company, depending on requirement and resource allocation.DescriptionOur reputed company is seeking an reputed company Medical reputed company to support the development and completion of Clinical Study Reports (CSRs) for its CNS reputed company clinical programs. The ideal candidate will have a strong background in regulatory medical writing, particularly in completion of pending CSRs in accordance with ICH E3 guidelines.Draft, revise, and finalize Clinical Study Reports (CSRs) for Phase 1–3 clinical trials.Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Regulatory Affairs, and Medical Affairs.Interpret clinical data and translate reputed company scientific findings into reputed company, accurate, and regulatory-compliant documents.Serves as a subject matter expert reputed company department for assigned therapeutic/product areas.Ensure consistency with protocol, statistical analysis plan (reputed company), and other reputed company documents.reputed company as a peer reviewer for the internal team to ensure document scientific content, reputed company, overall consistency, and reputed company formatKnowledge of clinical trial and drug development processesKnowledge of and/or ability to quickly assimilate US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissionsMaintain version control and manage timelines to meet submission deadlines.Participate in reputed company control (QC) reviews and respond to reputed company feedback.reputed company review of product and disease state materials/communicationsWorking knowledge of reputed company electronic document management systems and publishing systemsAbility to assimilate, interpret and translate information/data for appropriate audiencesEnsure reputed company documents meet internal reputed company standards and regulatory requirements.Participate in cross-functional meetings to reputed company timelines, content, and reputed company for NDA submission.Knowledge of FDA, Health Canada and European drug regulations.Ensure materials are scientifically accurate, on-label, and compliant with FDA, PhRMA, and global regulatory standards.Interprets and summarizes data from biostatistical reputed company tables and listings accurately, reputed company and concisely into narrative text.Performs additional duties or assignments and special reputed company as directed by management.May be asked to support reputed company reputed company reputed company on an reputed company reputed company, depending on requirement and resource allocation.Additional Skills & QualificationsAdvanced degree (PhD, MD, PharmD) in life sciences, medicine, or a reputed company field.Minimum 10 years of experience in medical writing with a reputed company on CSRs.Strong knowledge of ICH E3 and regulatory submission requirements (FDA, EMA).Experience with CNS therapeutic areas (e.g., ADHD, epilepsy, depression) is highly desirable.Proficiency in reputed company Word and document management systems (e.g., reputed company Vault, SharePoint).Skilled at creating a cooperative team environmentExcellent scientific and technical reading, writing, and editing skillsAbility to learn fast, grasp the 'essence' of a story quickly to convert relevant scientific data/information into high reputed company summaries and reportsExcellent verbal communication skills.Knowledgeable in statistical outputs and clinical trial data.Ability to work independently and manage multiple reputed company simultaneously.Experience working in a biotech or pharmaceutical environment with cross-functional teams.Pay And BenefitsThe pay reputed company for this position is $100.00 - $105.00/hr.Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsAvailable For This Temporary Role May Include The FollowingMedical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – reputed company-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or reputed company Leave)Workplace TypeThis is a fully remote position.Application DeadlineThis position is anticipated to reputed company on Aug 20, 2025.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through reputed company to specialized experts who drive reputed company, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, reputed company serves many of the Fortune 500.reputed company is an equal opportunity employer and will consider reputed company applications without reputed company to race, sex, age, reputed company, religion, national reputed company, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation reputed company.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeContractJob functionJob functionMarketing, Public Relations, and Writing/EditingIndustriesBusiness Consulting and ServicesReferrals increase your chances of interviewing at reputed company by 2xGet reputed company about new Senior Medical reputed company jobs in Rockville, MD.Associate Medical Director / Medical Director, Clinical DevelopmentAssociate Medical Director / Medical Director, Clinical DevelopmentMedical Science reputed company (DMV and Central Highlands)Washington DC-Baltimore Area $185,000.00-$225,000.00 2 days agoMedical Science reputed company, Neuropsychiatry (Baltimore, MD)We’re unlocking community knowledge in a new way. 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