Job Description
At Vertex, O ur Medical Writing Scientists are strategic partners in the drug development process, collaborating with cross functional teams to bring new, innovative, life-changing products to patients.
The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development.
This role may represent Medical Writing Science as a cross-functional team member for study-level and program-level activities.
This is a hybrid position which allows for 2 days per week remote work, and 3 days per week in the Boston Fan Pier office.
Key Duties and Responsibilities :
- Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders
- Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple programs or therapeutic areas
- Provides expert review of study-level and program-level documents
- Participates in developing key messages for complex clinical regulatory documents
- Provides leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program
- Provides strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline
- Contributes to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents
- Ensures document preparation is compliant with company and industry standards
- Strong contributor on cross-functional teams working on standard operating procedures, process improvements, and integration of new tools and technologies
Knowledge and Skills :
- Outstanding written and oral communication skills
- Extensive experience writing and editing clinical regulatory documents
- Ability to analyze, interpret, and summarize highly complex data
- Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- Ability to mediate conflicts by negotiating, compromising, persuading, and facilitating the open exchange of ideas and opinions
- Highly developed project management and organizational skills
- Ability to manage challenging, high-value projects
- Initiative and creativity in solving complex problems; ability to have a substantial role in developing and implementing improvements in cross-functional processes
Education and Experience :
- Ph.D. (or equivalent degree)
- Typically requires 6 years of experience or the equivalent combination of education and experience.
Senior Manager of Medical Writing Delivery and Excellence
The Senior Manager of Medical Writing Delivery and Excellence is a high-impact role, reporting directly to the Senior Director of Medical Writing Delivery and Excellence. As our Senior Manager of Medical Writing Delivery and Excellence, you will be more than a team member - you will be a crucial piv...
Life Science Audit Senior Manager
This Audit Senior Manager role will be based out of our. Withum's Life Sciences practice serves public and private clients, including growth oriented, private equity and venture backed technology companies and provides tremendous career opportunities in an environment of the highest ethical standard...
Senior Manager, Medical Economics
Manager of Medical Economics to join our Medicare Population Health Programs (MPHP) team to lead the team’s overall Value-based Care data, analytics and evaluation strategy. As we continue to expand our capacity to provide human-centered, tech-forward care to patients across generations, the teams t...
Senior Medical Science Liaison Psychiatry - Northeast
The Senior MSL, Psychiatry will apply advanced field based medical and scientific experience, subject matter knowledge, and skills in supporting medical strategies for Lundbeck compounds. Applies advanced medical and scientific experience, subject matter expertise, and communication skills in suppor...
Senior Manager, Data Science - Business Card & Payments
New York City (Hybrid On-Site): $234,700 - $267,900 for Sr Mgr, Data Science. Partner with a cross-functional team of data scientists, software engineers, and product managers to deliver a product customers love. You have hands-on experience developing data science solutions using open-source tools ...
Senior Manager, Quality Assurance - Medical Device
Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part /, Part , ISO and Canadian Medical Devices Regulations (CMDR SOR/98-), EU Medical Device Regulation /. Responsible for all aspects of QA for Medical Device...
Payer Product Marketing Senior Manager
The Payor Product Marketing Senior Manager is an individual contributor role responsible for driving the success of Exact Sciences payer-focused initiatives. Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and ...
Senior Manager, US Medical Ad/Promo Regulatory Review
Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. This position is currently classified as "hybrid" in accordance w...
Senior Manager, Medical Excellence
Senior Manager level role that designs and develops the US Medical Affairs capability strategy and execution. Drives medical excellence of US Medical Affairs members for both Head Office and Field teams, and builds capabilities within US Medical Affairs to enable high level of performance. Optimizes...
Compliance Senior Manager
The Compliance Senior Manager for Trinity Partners, LLC. Lead Trinity’s internal client auditing and external client audit activities, which requires working knowledge of Life Science regulatory requirements contractually passed through to its vendors like Trinity (e. Ten (10) years of experience is...