Associate Director Medical Writing
Associate Director Medical Writing
Senior
Undisclosed
Full Time
4 Year Degree
Undisclosed
Undisclosed
Undisclosed
Biotech
Description

Company Summary:

Aeglea BioTherapeutics, Inc. is an Austin, TX based clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer. The Company is developing pegzilarginase, its lead investigational therapy, for the treatment of Arginase 1 Deficiency, as monotherapy in arginine-dependent cancers and in combination with an immune checkpoint inhibitor for small cell lung cancer. In addition, Aeglea has an active research pipeline of other human enzyme-based approaches in both therapeutic areas.

 

Position Summary:

The Associate Director 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. This position coordinates all activities required to produce medical writing deliverables assigned to them, negotiates and manages timelines, and as required directs the work of other medical writers.

 

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

  • Work independently using knowledge and experience to prepare, edit and finalize protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
  • Partner with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
  • Apply technical and line knowledge to plan and co-ordinate all aspects of timelines for assigned medical writing deliverables to align with project goals and enable the function to meet its goals. Work closely with the study team to reach consensus on timelines for deliverables
  • Alert project/ line management of possible timeline delays and propose mitigation strategies as appropriate
  • Work closely and independently with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
  • Schedule and conduct document-related meetings including the preparation of the pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Develop constructive relationships with cross-functional project team and work group members to support effective team interactions. Collaborate with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
  • Lead and manage the document preparation team through the review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
  • As required, supervise and/or coordinate the work of contract medical writers to meet company goals
  • Complete documents according to agreed-upon timelines and follow up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
  • Understand the functions and roles within the study team and align with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
  • Ensure that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines. May provide guidance to project teams on such guidelines where relevant
  • Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system; identify potential areas for improvement in processes, templates etc.
  • Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements
  • Provide expertise on regulatory guidance as it relates to the preparation and submission of documents to regulatory authorities
  • Completed work is reviewed for achievement of results. May be required to review work completed by other colleagues
Qualifications

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.

 

Experience:

  • 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
  • Decision-making
  • Effective decision-making skills that may require developing innovative options to resolve complex problems
  • Able to troubleshoot to effectively solve problems within the function

Autonomy

  • 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

Innovation

  • 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.

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