Kelly is currently seeking a Associate Director Medical Writer Lead for one of the largest global pharmaceutical companies in the world. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc.
This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise.
Write and edit clinical regulatory documents (all document types) including responses to Health Authority Agencies.
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
Must have previous experience as Medical Writer lead in Pharma/Biotech companies.
Must have previous experience with writing and editing clinical regulatory documents (all document types) including responses to Health Authority Agencies.
Able to work with tight deadlines
Attention to details
Master's degree preferred but open to BS degree in Life Sciences (or other related field), both with a minimum of 7 years of experience.
Native English speaker with extensive knowledge of English grammar, including familiarity with a standard style guide
Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts preferred
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
Previous experience working globally
CNS experience preferred
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At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.