Job Title: Director, Medical Communication (depending on experience)
Reports to: Vice President Regulatory and Medical Affairs
Classification: Full-time, FLSA Exempt, Salary
Educational requirements:
Minimum: BA/BS in biology, chemistry, pharmacy, nursing Desired: MS in a scientific discipline and certificated by AMWA or CMPP
Experience:
Minimum: 5-8 years of medical writing/management
Desired: 10-12 years
Core skills:
– Extensive native speaker fluency in English
– Familiarity with standard style guides and relevant commercial products
– Ability to communicate scientific or medical information in a clear and concise manner, verbally and in writing
– Advanced proficiency in Word, Excel, PowerPoint, email, and the Internet
– Familiarity with the principles of clinical research and drug development process
– Ability to interpret and present clinical data and other complex information
Advanced skills:
– Compile, write, and edit medical writing deliverables covering all phases of clinical research for submission to regulatory agencies
– Oversee and manage external Medical Writers for specific writing projects
– Write or oversee preparation of manuscripts intended for publication in medical journals, or for internal company use
– Ability to develop a library consolidating all published literature relevant to therapeutic areas of interest and assets
– Ability to respond to ad hoc writing/editing requests including but not limited to short reports,internal and external meeting materials, reviewer comments, regulatory and commercial initiatives
Essential Duties and Responsibilities:
– Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents such as abstracts, posters, presentations, and manuscripts
– Participates in scientific communication planning, including development of strategic medical communication plans
– Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
– Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
– Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
– Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
– Works closely with the study team to reach consensus on timelines for deliverables
– Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
– Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
– Manages all aspects of outsourced or internal production and ensures project delivery
– Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
– Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
– Ensures that documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
– Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
– Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
– Align with department management to set strategy for meeting department goals