SUMMARY:
Lead and direct medical writing of clinical and scientific documents for clinical trials/programs, as well as publication activities, covering all phases of clinical research and in various therapeutic areas, within established timelines.
DUTIES AND RESPONSIBILITIES:
- Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas that include but not limited to clinical study protocols and clinical protocol amendments; clinical study reports; clinical development plans; IND submissions and annual reports; Integrated summary reports; NDA/BLA and (e)CTD submissions; investigator brochures, as well as; clinical journal manuscripts, clinical journal abstracts, and presentations.
- Plans and coordinates report-writing activities with other functions, including Clinical Operations, Pharmacovigilance, Regulatory and other groups.
- Compiles, writes, and edits medical writing deliverables within established timelines, with minimal supervision, and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
- Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, and Company approved templates when completing medical writing projects.
- Performs other work-related duties as assigned.
QUALIFICATIONS:
- Minimum of 5 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting
- Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified.
- Experiences in preparing and coordinating documents (e.g., protocols, study reports, investigator brochures, safety updates, and clinical sections in CTD regulatory dossiers)
- Attention to detail with an ability to perform a critical review of various types of documents
- Demonstrated ability to communicate and write clearly, concisely, and effectively, with an aptitude for compilation, analysis, and presentation of data
- Ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to demanding timelines
- Knowledge of drug development, clinical research, study design, biostatistics, regulatory environment, and medical terminology
- Demonstrated ability to work as a team player with multi-disciplinary and cross-cultural project teams
- Independently motivated, good problem-solving ability, with excellent oral and written communication skills
COMPETENCIES
- Problem Solving–Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Reasons when dealing with emotional issues.
- Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things.
- Communication–Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs.
- Leadership–Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Ethics–Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
- Strategic Thinking–Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
- Judgment–Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
- Initiative–Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
- Innovation–Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others’ attention.
Please apply by sending your resume (.pdf format) to [email protected].
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Brii Biosciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic.
Brii Biosciences
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