Senior Medical Writer (Rockville, MD)

The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.
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
• Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
• 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
• Collaborate with clinicians, clinical scientists, biostatisticians, and pharmacokinetics 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 comments are appropriately addressed
• Completes documents according to agreed-upon timelines and follow-up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance and reach consensus on timelines for deliverables
• 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 CSR production and ensures project delivery
• Ensures that medical writing deliverables conform to the 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 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 to improve quality, efficiency, and productivity
• Aligning with department management to set strategy for meeting department goals

• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
• Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
• Read, write and speak fluent English, excellent verbal and written communication skills
• Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses.
• Excellent writing skills coupled with knowledge of the drug development process and regulatory guidelines.
• Effective collaborator with ability to foster strong working relationships and build consensus among colleagues on cross-functional teams.
• Initiative and ability to handle a variety of projects simultaneously.
• Excellent interpersonal and communication skills.
• Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT.

• (BA/BS) +8 years, (MS) +5 years, (Ph.D. or PharmD) Doctoral Degree+2 years of relevant corporate medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas;
• 3 -8 years of regulatory writing and submission experience
• An understanding of the drug development process
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
• Experience in interacting with cross-functional study team members