• Ensures appropriate Medical Writing deliverables planning for projects and programs, including resource forecasting, timelines, and budget; resource allocation; reporting on status of deliverables for projects and programs.
• Works with executive management to establish/renegotiate timelines for drug development program planning.
• For outsourced projects, manages development of requests for proposal (RFPs), evaluation of bids, negotiation of contracts, and vendor management.
• Accountable for documentation deliverables quality and ensures work on assigned projects adheres to departmental procedures and practices and technical and industry standards.
• Develops and leads the Medical Writing department recruitment process and participates in broader BioMetrics recruitment activities.
• Guides development/tracks status of Medical Writing related SOPs, templates, work process documents, Style Guide, or content guidelines
  Contributes to development of SOPs for BioMetrics, as needed.
• Ensures implementation Medical Writing training curriculum.
• Establishes adaptive mentoring and coaching practices for Medical Writers.
  Establishes goals for direct reports that align with those of the BioMetrics department and the company.
• Conducts performance evaluations for direct reports against established goals.
• Builds effective partnerships with cross-functional groups within BioMetrics and the company to ensure customer/stakeholder needs are met.
• Leads departmental or cross-functional special project teams focused on improving business operations and process improvement.
• May manage the writing effort of contract writer(s) to complete deliverables.
• Performs regulatory intelligence for information pertinent to Medical Writing and provide preliminary assessment of impact of new or modified regulations and guidances.

Requirements:

Must have at least 12 years of experience in medical writing in the pharmaceutical industry

Management

• Minimum of 6 years administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting.
• Demonstrated leadership abilities.
• Demonstrated ability to plan timelines and resources for multiple documentation projects with shifting priorities.
• Experience with budgeting documentation projects.
• Experience selecting vendors, establishing working relationships with vendors, and overseeing vendor deliverables.
• Experience establishing partnerships with cross-functional groups in a clinical development setting.
• Experience with delegating and overseeing projects and tasks.
• Experience with establishing departmental and company-level processes and procedures.
• Experience coaching or mentoring medical writers both in behavioral and technical areas.

• Up to 2 medical Writing Manager(s) as direct reports.
• Up to 5 Medical Writers as functional reports.
• One project co-ordinator as functional report.
• May also manage the writing effort of contractor(s).

Specific Technical Requirements

• Computer/office Equipment Skills: Able to mentor or train others in the use of: Microsoft Word (including the use of templates), Excel, PowerPoint, Adobe Acrobat, Visio, SigmaPlot or other graphic/flowchart software, MS Project, and document management software (eg, LiveLink, Documentum).
• Clinical Studies: Advanced understanding of the drug development process (discovery to market), clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.
• Advanced applied knowledge of: documentation required for the conduct of clinical studies; protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs); study results reporting; integrated results reporting; direct experience with documentation in all phases of drug development.
• Medical Writing: Able to mentor, train, or manage others in using style guides (AMA, CBE, and Chicago), medical dictionaries, and guidance documents that prescribe content; interpreting data from tables and graphs; creating complex tables; interpreting basic clinical laboratory tests; researching literature and interviewing subject matter experts; understanding concepts of coding dictionaries (MedDRA, WHO Drug); understanding biostatistical and clinical research concepts; understanding scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection; writing high-quality documents that support corporate goals and objectives.
• Regulatory: Ability to plan and manage development of the following documents in context of regulatory requirements and guidances, development program plans, and organizational business needs:
  "standalone" regulatory documents (eg, protocols, investigator brochures, clinical study reports, IND annual reports); Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format; Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE); ability to assist in the planning and development of the following documents: clinical sections of pre-submission meeting packages (eg, pre-IND or end-of-Phase 2 meetings), Orphan Drug Applications, CTAs, IMPDs, etc.; Targeted Product Profile, Package Inserts/Product Labels (using structured product labeling guidelines);
  responses to FDA queries and inspection findings; support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US and EMEA submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances; ability to provide leadership for presentations to regulatory authorities and regulatory inspections.

Skills, Industry, or Educational Experience Requirement Details

• Ideal industry experience: 5+ years
• Masters (MS or MA) or higher degree preferred; scientific focus desirable.
• Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.
• 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.

For more information, contact: