To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required.
Education: The ideal candidate will offer:
- At minimum Bachelor’s degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
- Bachelor’s degree + 12 years, Master’s Degree +8 years, Doctoral Degree +2 year of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas; graduate degree (master’s or doctoral) preferred
- At least 1 years’ experience of oversight/ supervision of contract Medical Writers
Knowledge, Skills and Abilities:
- Able to read, write and speak fluent English; excellent verbal and written communication skills
- Technical Expertise
- A comprehensive understanding of the drug development process
- Comprehensive knowledge of the principles, concepts and theories of Medical Writing and broad knowledge of the principles and concepts of other disciplines
- Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
- Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
- Ability to apply technical and line knowledge to plan/design and manage projects
Teamwork and Collaboration
- Ability to develop constructive relationships across disciplines and functions; establishes and maintains professional and productive working relationships with team members
- Well-developed interpersonal, active listening, and influencing skills
- Experience in interacting with cross functional study team members
- Effective decision-making skills that may require developing innovative options to resolve complex problems
- Able to troubleshoot to effectively solve problems within the function
- Ability to work independently using knowledge and work experience in ambiguous situations within a work group/ project team/ function.
- Ability to multi-task and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details. May help others to prioritize and manage work
- Ability to communicate and influence with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; define solutions to complex issues and where needed, escalate appropriately
- Ability to apply business knowledge to effectively assess and manage/ mitigate risks to advance innovative processes and methodologies
Work Environment: This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 10 % of work time.
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.
Light physical activity performing non-strenuous daily activities of an administrative nature. Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time. Manual dexterity sufficient to reach/handle items and work with the fingers. Use of hands to fingers for typing and other computer activity for up to 75% of your time. Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time. Ability to lift, up to 25lbs, less than 25% of the time.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Notice to Recruiters/Placement Agencies:
To protect the interests of all parties, Aeglea BioTherapeutics, Inc. will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to Aeglea, including unsolicited resumes sent to an Aeglea's mailing address, fax machine, our geneal inbox/email address, or directly to employees, will be considered Aeglea property. Aeglea will not pay a fee for any placement resulting from the receipt of an unsolicited resume. Aeglea will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.
Recruiting agencies must obtain advance written approval from Aeglea’s Human Resources department to submit resumes, and then only in conjunction with a valid fully-executed contract for service and in response to a specific job opening. Aeglea will not pay a fee to any Agency that does not have such agreement in place.