Senior Medical Writing Director

SUMMARY/JOB PURPOSE:

Writes and edits various documents to support Product Development. Such documents may include clinical study reports (CSRs), common technical document (CTD) summaries for submission to regulatory agencies, protocols, Investigator Brochures, literature reviews, study manuals, and standard operating procedures (SOPs). Assembles CSR and CTD summary appendices and narratives. Requires knowledge of company policies and technical platforms, product areas, current developments, and keeping abreast of current literature.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Writes and edits CSRs, CTD summaries, protocols, investigators brochures, and other clinical trial documentation as necessary for submission to regulatory agencies and other stakeholders or for in-company use.
• Proposes and manages timelines for document preparation and review
• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed.
• Integrates various sources of information into a uniform style and language for regulatory compliance.
• Assembles CSR and CTD summary appendices and narratives
• Serves as the MW expert on regular and ad hoc study, program, or project teams.
• Leads and manages teams of medical writers in complex projects by providing guidance based on organizational goals and company policy, with responsibility for results.
• Guides and advises Medical Writing contributors as a function of program representation. This responsibility may include document review.
• Performs quality checks of documents prepared by other medical writers as needed.
• Proposes opportunities for process improvement and leads projects to enhance efficiency and optimize the use of resources
• Other duties as needed.

SUPERVISORY RESPONSIBILITIES:

• No direct reports
• Provides asset-level strategic guidance to study-level MW representatives
• Mentors less experienced medical writers
• Supports and directs the work of contract medical writers

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of fifteen years of related experience; or,
• MS/MA degree in related discipline and a minimum of thirteen years of related experience; or,
• PhD in related discipline and a minimum of twelve years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Experience in Biotech/Pharmaceutical industry required.
• Nine to eleven years of medical writing or equivalent writing experience in the pharmaceutical industry.
• Experience and significant participation in preparation of documents for regulatory submissions (e.g., clinical protocols, INDs, NDAs, BLAs, CTDs).
• Experience and use of electronic literature tools to obtain reprints of abstracts and medical publications.

Knowledge/Skills:

• Familiarity with therapeutic area of oncology is essential.
• Good/general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs, and Clinical Development.
• Excellent writing ability with strong attention to detail.
• Proficient in Windows suite.
• Ability to independently develop high-quality complex documents
• Familiarity with document management systems is essential.
• Directs a variety of complicated tasks with a wide degree of strategic flair (eg, by direct contact with personnel at other organizations), independence, creativity, and latitude.
• Identifies and implements methods and procedures to achieve results.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Has good general knowledge of other related disciplines.
• Has good timeline development and management skills
• Applies strong analytical and business communication skills.

JOB COMPLEXITY:

• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. High degree of independent work and strategic flair required.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.
• Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work

#LI-JD1