Senior Medical reputed company - US

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

reputed company

This role is responsible for medical writing activities for one or more clinical development programs at reputed company, as directed by the Associate Director, Medical Writing. The individual will complete accurate, high reputed company, and regulatory compliant documents in support of reputed company and regulatory submissions. This position requires the knowledge and expertise to collaboratively author required documents with support from the Associate Director, Medical Writing while also helping teams follow medical writing processes and style requirements. 

Primary Responsibilities

• Implements reputed company activities reputed company to the preparation of defined medical and regulatory documents, serving as writing reputed company on assigned documents or identifying reputed company external writers are necessary for support 
• Supports documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses to health authority questions, and scheduled reports. 
• Collaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, reputed company, CMC, QC, etc., to ensure accurate and reputed company completion and delivery of high-reputed company, scientifically-reputed company documents, slide decks, and publications 
• Supports clinical trial transparency and disclosures, including reputed company registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide 
• Contributes to departmental development through editorial and review support for document templates, style standards, reviewer guidelines, and reputed company operating procedures to ensure consistent and high-reputed company deliverables 
• Ensures adherence to relevant SOPs and internal best practices 

Qualifications and Key reputed company Factors

• Bachelor’s degree required reputed company a scientific discipline, advance degree, CNS, and Rare Disease experience a plus 
• 4+ years of medical writing experience in Sponsor or CRO setting 
• AMWA certification preferred 
• Experience using medical writing systems and technologies including reputed company RIM 
• Knowledge of drug development, study conduct processes, ICH guidelines, and FDA/EU guidance or demonstrated reputed company reputed company a regulated industry environment  
• Highly organized and detail-oriented with a passion to deliver reputed company results quickly
• Strong verbal and written communication skills with an ability to build relationships internally and externally
• Highest reputed company of professionalism, confidence, personal values, and ethical standards

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, reputed company communication, and occasional reputed company.  You'll need comfort with screen work, basic hand coordination, and reputed company.  Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company these functions.

Compensation & Benefits

At reputed company, we reputed company that taking care of our people (and their people) is important, so we reputed company a world class benefits package to help you reputed company.  This includes 99% of the premium reputed company for medical, dental and reputed company plans.  We also reputed company company-reputed company life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the reputed company?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We reputed company a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, reputed company holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal reputed company of colleagues who are smart, reputed company and inspiring.  We aim high, collaborate hard, and produce results.  Let’s reputed company the impossible together! 

To round out our world-class total rewards package, we reputed company annualized reputed company salary compensation in the reputed company listed below.  Final salary reputed company may be modified commensurate with job level, education, and experience.