MEI Pharma's staff is a team of friendly, dedicated, experienced and collaborative professionals committed to the hard work that supports our company's aggressive goals and to the workplace values that promote our success.
Our workplace values include:
- Shared commitement to excellence and collaboration across functions
- Personal accountability for consistent superior performance
- Fiscal discipline applied wisely in the use of resources
- Mutual trust and respect for individual differences
- Dedication to developing novel therapies for our patients
We are currently seeking applicants for the following open positions. If your qualifications match the job requirements, please submit your resume for consideration to email@example.com.
Senior Medical Writer
MEI’s Clinical Development Department seeks a Senior Medical Writer with scientific knowledge and writing expertise to effectively communicate technical pharmaceutical drug and scientific medical information to regulatory authorities, clinical study sites, and thought leaders involved in cancer drug development. The position’s particular focus includes protocol development, regulatory submissions, and scientific manuscripts and abstracts. The position works closely with cross-functional team members to ensure the documents are high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, eCTD requirements and company goals. The core duties of the medical writer are delineated below.
Responsibilities and Duties:
- Write, edit and collaborate on development of preclinical, clinical and sections of regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, DSURs, INDs, eCTD/NDA modules, clinical summaries, briefing books)
- Compile, write, and edit documents covering all phases of MEI’s clinical oncology/ hematology research, to include integrated summaries of data, risk/benefit analysis, etc.
- Assist in the analysis, synthesis and presentation of complex information for scientific presentations
- Distill large amounts of clinical and scientific data into essential elements for graphical display.
- Draft manuscripts, abstracts and posters for submission to medical journals and/or scientific meetings.
- Provide QC review support as needed and ensure consistency between related documents
- Understand the levels of evidence required to achieve regulatory and clinical trial goals. Ability to coordinate, plan and manage communications to enable timely review from other authors and reviewers and to function as a collaborative team member.
- Formulate key messages from clinical study data
- Perform literature-based research to support writing activities
- Develop and maintain medical writing processes, SOPs, templates and outlines for key documents
- Maintain an awareness of current industry practices and regulatory requirements that affect medical writing.
- Keep abreast of current literature, emerging science, technological developments and medical trends.
- Write summaries and maintain files on informative medical and scientific journal articles.
- BS, MS or doctorate in a scientific or medical discipline with relevant experience
- 5+ years’ experience in the medical/regulatory/publication writing and editing
- Experience in a Medical specialty –oncology/hematology is a plus
- Basic to intermediate knowledge of biostatistical and clinical research concepts
- Thorough understanding of FDA and ICH regulations and guidelines
- Experience authoring/editing CSRs and other types of clinical regulatory documents (e.g., clinical protocols, Investigator’s Brochures, NDA modules) or scientific publications including abstracts and posters
- Proven ability to implement medical writing processes and standards
- Knowledge of Microsoft Office applications and electronic document management systems; proficiency in Word, Excel, PowerPoint, email, and the Internet.
- Willingness and ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment; adapts to changing deadlines and priorities.
- Ability to work collaboratively to coordinate the efforts of team members to complete deliverables.
- Exceptional oral and written communication skills
- Flexible, adapts work style to meet organization needs
- Motivated, self-directed and able to work autonomously and in team settings to meet aggressive organizational goals
- Available writing samples for MEI review.
- Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
- Regular communication (hearing/speaking).
- Lifting up to 25 lbs.
- Routine office duties including computer keyboard use
- Vision requirements include: close vision and ability to focus.
- Noise conditions range from quiet to moderate.
Equal Opportunity Employer:
MEI Pharma, Inc.'s policy is to provide equal opportunities to all employees and employment applicants without regard to unlawful considerations of race, color, national ancestry, sex, gender, age, religion, physical or mental disability, medical condition, genetic information, pregnancy, marital status, sexual orientation, gender identity, gender expression, military or veteran status or any other classification protected by applicable local, state or federal laws.
The recruitment and employment process at MEI Pharma, Inc. is managed exclusively through the Human Resources Department with all candidates applying directly in this manner. The company does not accept unsolicited resumes from any source other than from qualified candidates and only for current open positions.