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Medical Writer

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

Categories
career

Medical Writer

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