Senior Medical Writer

• Bachelor’s or higher degree required; scientific focus desirable.
• Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

• Up to 6 years of as a medical writer in the pharmaceutical industry – OR - at least 10 years of medical or scientific writing experience as a primary job responsibility.

1) Medical Writing:

• Experience writing, reviewing, or editing protocols and clinical study reports required.
• Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred.
• Experience writing, reviewing, or editing regulatory briefing books preferred.
• Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.
• Ability to interpret and create complex tabular and graphical clinical data presentations.
• Advanced applied knowledge of basic clinical laboratory tests.
• Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• 2) Clinical Studies
• Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.
• Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.
• Intermediate to advanced applied knowledge of:

o documentation required for the conduct of clinical studies

o protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)

o study results reporting

o integrated results reporting

• Direct experience with documentation in all phases of drug development.
• 3) Regulatory
• Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
• Prior familiarity with standard eCTD IND/NDA work, including:

o Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format

o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)

• 4) Project Management
• Capable of working on multiple tasks and shifting priorities.
• Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
• Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflicts.
• Good conflict management skills.
• Motivated and shows initiative.
• Detail oriented.
• 5) Communication
• Capable of well organized, concise and clear written and verbal communication.
• Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
• Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced presentation skills.

• Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
• Experience using document management software (eg, LiveLink, SharePoint, Veeva)
• Experienced with scanners, printers, and copiers.
• Note: This description is not intended to be all-inclusive
• or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
• Equal Opportunity Employer/Veterans/Disabled
• An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race
• or protected veteran status and will not be discriminated against on the basis of disability.