$200K — $250K *
Your new position will report to the Director, Head of Global Regulatory Writing, Medical Writing
• Writes and/or edits clinical regulatory documents (all document types).
• Prepares regulatory documents (eg, Module 2 and other clinical CTD documents, briefing and response documents [requests for information, deficiency letters], pediatric clinical development plans). Ensures documents are accurate, complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
• Guides clinical (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
• Provides leadership/strategy at the therapeutic area level for documents and complex submissions
• Contributes at the program, submission team, and therapeutic area level.
• Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
• Ensures quality assurance of own documents - implementation of comments received from CQA.
• Works independently and collaboratively in a cross-functional global team
• Communicates information clearly and concisely
• Manages preparation of clinical documents for submissions
• Participates in CDTs and study team meetings, provides alignment with documents within overall program strategy
• Lead CRMs and sets up document reviews as needed (eg, if MW doesn’t have access to Teva systems or have a Teva systems superuser)
• Prepares or reviews and maintains document timelines
• Uses various tools, business systems, and repositories
• Provides oversight of assigned internal and external medical writers to deliver high-quality documents on time, consistent with internal standards, and within budget
• Oversees/mentors for all document types
• Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities
• Responsible for tracking/proving metrics and established key performance indicators, contributing to the budget process, and handling invoices
• Identifies processes that require improvement, and demonstrates “big picture” perspective, leveraging experience, to recommend strategies and solutions
• Contributes to manuscript preparation as needed
• Ph.D. or a Master's degree in Life Sciences (or other related field), both with a minimum of 10 years of experience.
• Native English speaker with extensive knowledge of English grammar, including familiarity with a standard style guide
• At least 7 years writing experience of clinical regulatory documents in the Biopharmaceutical/CRO industry.
• Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts.
• Ability to interpret, communicate and write scientific and clinical data in a clear and concise manner.
• Strong communications, organizational, time management, and project management skills are required.
• Proficient in MS Word and experience with document templates
• Experience with an electronic document management system
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
• Familiarity with the principles of clinical research and drug development, including clinical trial design, operations, and results analysis
• Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA)
• Experience managing direct and indirect reports, including medical writing contractors
• Ability to plan, manage, and optimize resources
• Strong leadership, conflict-resolution and influencing skills
• Attention to detail
• Works successfully with little direct supervision
• Working knowledge of clinicaltrials.gov and clinicaltrialsregister.eu databases
• Proficiency in conducting literature searches and working knowledge of relevant databases
Valid through: 6/29/2021