The Medical Writer will lead medical writing activities for clinical documentation preparation to support the advancement of clinical-stage programs.
- Coordinate the preparation and timely delivery of high-quality documents for domestic and international regulatory filing and clinical programs.
- Produce documents to support clinical trials and regulatory submissions, in accordance with domestic and international regulations and guidelines
- Prepare detailed timelines of writing activities for assigned documents and validate dates with all impacted document production team members
- Ensure coverage of writing activities in accordance with the project objectives and project specific milestones dates
- Research and recommend external partners, and monitor the quality and progress of subcontracted writing activities
- Lead the development of clinical protocols and amendments, investigator’s brochures (IBs), clinical study reports (CSRs), investigational new drug (IND) applications and clinical documents to support HA submissions for product candidates
- Actively support the clinical and/or scientific team, and take responsibility for timely and accurate Medical Writing deliverables.
- Lead the development of standard operating procedures (SOPs) for improved efficiencies in clinical document production, editorial style guides, clinical document templates, clinical document publishing, and implementation of content management systems to ensure consistent and high-quality clinical documents.
Education, prior work experience, and specialized skills and knowledge:
- MS or PhD in a relevant scientific field is strongly preferred. A minimum of 5+ years Medical Writing experience in the biopharmaceutical industry
- In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Prior experience with IND/CTA/NDA/BLA/MAA submissions and expertise in requirements, including eCTD standards
- Knowledge of clinical trial transparency requirements; familiarity with submissions to clinical trial registries (ClinicalTrials.gov, EudraCT)
- Demonstrated proficiencies in MS Word and PowerPoint, Document Review and SharePoint software (e.g. PleaseReviewTM)
- Excellent written and verbal communication skills, with the ability to clearly present clinical data.
Strong organizational skills with the ability to effectively multi-task and prioritize.
- Flexibility/adaptability to working in a fast-paced and dynamic environment and to changing business needs and meet deadlines.
- Strong attention to detail and ability to complete writing assignments in a timely manner.
- Ability to work independently and collectively in teams.
- Collaboration & Teamwork: Advanced competence in collaboration & teamwork, communications influence, strategic agility, planning & organizing, driving results, and problem solving.
- Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Communication/Presentation Skills: Excellent ability to convey both written and verbal information effectively and efficiently and present information to all levels of audiences.
- Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
- Leadership: Strong ability to establish and communicate clear visioning that team members willingly follow; provide information, knowledge and methods to realize that vision; coordinate and balance conflicting internal and external interests; ability to influence decision-making in a diplomatic manner. Able to navigate team smoothly through difficult situations.
- Strategic Thinking: Capable of thinking conceptually, imaginatively, systematically, and opportunistically to achieve company goals.
How to Apply
Please complete the application below and include the following attachments:
- Cover Letter
- CV / Resume
- Research Summary (if applicable)
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta’s research and development programs include clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV).
Enanta’s research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.
Enanta Pharmaceuticals is an equal opportunity employer (EOE) with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law.
This is a full time position