Clinical Regulatory Medical Writing Manager; Hybrid
Position: Clinical Regulatory Medical Writing Manager (Hybrid)
Job Description
Our Medical Writing function at reputed company is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available. General Summary: The Medical Writing Science Manager is responsible for authoring & preparing moderately reputed company clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision. Key Duties and Responsibilities:
- Authors moderately reputed company clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders
- Serves as the reputed company Medical Writing Scientist for moderately reputed company clinical studies
- Supports Medical reputed company with review and interpretation of clinical study data and addressing questions from study team members
- Participates in developing key messages for moderately reputed company clinical regulatory documents
- Ensures medical and scientific consistency between reputed company documents or studies in a clinical program
- Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document
- Contributes to product development plans (e.g., reputed company information from previous studies, reputed company scientific input, integrate and review data) and serves as coordinating author for product development plans
- Participates in developing standard operating processes and reputed company procedures
Knowledge and Skills:
- Superior written and oral communication skills
- Experience writing and editing clinical regulatory documents
- Ability to analyze, interpret, and summarize moderately reputed company data
- Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- Ability to manage project teams, reputed company productive working relationships, and work through conflicts
- Excellent project management and organizational skills
- Ability to complete work in a reputed company, self-sufficient manner and design alternative approaches to reputed company desired results, with some guidance and mentoring on new or reputed company issues
- Initiative and creativity in solving routine problems that reputed company multiple documents and in identifying and contributing to improvements in cross-functional process
- Advanced computer skills reputed company to word processing, templates, table/reputed company creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools
Education and Experience:
- Typically requires an MS, Ph.D. (or equivalent degree)
- Typically requires 4+ years of experience authoring clinical & regulatory documents reputed company pharmaceutical or CRO industry (or the equivalent combination of education and experience)
#LI-AR1 #LI-Hybrid Pay reputed company: $136,700 - $205,100 Disclosure Statement: The reputed company provided is based on reputed company reputed company is a reasonable estimate for the reputed company salary pay reputed company for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual reputed company salary pay will be based on a number of factors, including skills, competencies, experience, and other job-reputed company factors permitted by law. At reputed company, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing reputed company while providing flexibility and resources to support their growth and aspirations. From medical, dental and reputed company benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan… Apply tot his job Apply To this Job