Senior Medical Writer

Location
San Diego, CA, US
Posted
Aug 30, 2020
Ref
325185
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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 Functions
  • Leads development and writing of clinical and nonclinical regulatory documents (preclinical, clinical and sections of regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, DSURs, INDs, eCTD/BLA modules, clinical summaries, briefing books) and summaries in accordance with predefined, aggressive timelines.
  • Assists with overseeing projects assigned to consultants and CROs, including timeline development and management.
  • Evaluates draft documents and draft statistical output for accuracy and consistency.
  • Represents the function and provides status updates at internal meetings and meetings with external collaborators.
  • Supports the timely generation of high-quality regulatory documentation by assuming other duties, including document editing, quality control review, and formatting.
  • Assists the function head with developing working practices and SOPs.
  • Assists in the analysis, synthesis and presentation of complex information for scientific presentations.
  • Distills large amounts of clinical and scientific data into essential elements for graphical display and formulate key messages from clinical study data.
  • Provides QC review support as needed and ensure consistency between related documents.
  • Ability to coordinate, plan and manage communications.
  • Develops and maintains medical writing processes, SOPs, templates and outlines for key documents.

Supervisory Responsibilities

None

Knowledge and Competencies
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations. 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.


Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The noise level in the work environment is usually moderate.
  • May be required to travel by plane or car.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Requirements

Education & Experience
  • A minimum of 5 years medical writing experience within the bio pharmaceutical industry or a contract research organization.
  • Bachelor's degree, or equivalent, in Science related discipline. Post-graduate qualifications preferred (MS, PhD or MD preferred).
  • A solid understanding of the clinical development process, including the documents that are required at each stage.
  • Excellent written, verbal and presentation skills.
  • Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
  • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations
  • Comprehensive understanding of medical writing for clinical development, including the documents required at each stage and their associated regulatory requirements.