Lead Consultant, Medical Writer
Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran’s Clinical Development & Operations team as a Lead Consultant, Medical Writer today!
In this role, you will use your understanding of the scientific and tactical elements needed to translate, author, and review regulatory dossiers and clinical documents. You will apply your cross-functional adeptness to ensure that our internal and client-facing results are robust and embrace industry standards.
- Translate scientific and tactical concepts into a variety of clinical and regulatory documents as appropriate in partnership with various teams and specialists
- Author documents that advance client objectives and overall project delivery, including those that utilize your understanding of the scientific aspects of clinical programs
- Lead all authors and subject matter authorities in the development of documents, including suggesting timelines and resolving issues as they arise so as to ensure on time delivery of high quality, accurate documents
- Develop new standards and templates for Halloran usage that embrace emerging ICH guidelines and evolving medical writing standard methodologies
- Review for completeness, quality and proper formatting of all documents
- Establish project scope, expectations, plan, and details that ensure high quality, timely and in budget results
- Supervise, analyze, and report project status, utilizing appropriate communication methods to update and solicit approval from internal and client partners
- Identify, mitigate and analyze the impact of any project risks, supporting timely resolution and client-facing response
- Educate existing and potential clients on Halloran services and opportunities for partnerships, authoring proposals and statements of work
- Participate in internal activities such as invoicing, bookings, developing new product offerings and consulting services, serving on internal process optimization activities and speaking publicly at conferences and workshops
- Mentor and lead internal Halloran team members to ensure success of company and client goals, in direct management, project-based, or matrixed relationships
- Other duties and responsibilities as assigned
- Bachelor’s Degree and a minimum of ten years of experience in a biotechnology or pharmaceutical setting
- Experience authoring scientific sections of a variety of clinical and regulatory documents (e.g., IB’s, study protocols, clinical study reports, Pre-INDs, INDs, annual reports, special designations, BLAs, and NDAs).
- Deep familiarity with current regulatory guidance, good quality practices (GxPs), legislation, industry trends, and health care and business practices in drug development
- Ability to work creatively and analytically to manage multiple priorities, tasks, and complex issues using logical and efficient processes while still keeping a high level of attention to detail and quality of work throughout the entirety of the project life cycle
- Exercise good judgment in selection methods, techniques and evaluation criteria for obtaining results to solve complex issues that may require in-depth evaluation of variable factors
- Experience with pre-clinical research
- Advanced degree in Life Sciences
The targeted gross compensation range for this position is between $120,000.00 and $175,000.00 annually. Please note: this compensation range is Halloran’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, Halloran may ultimately pay more or less than the posted range.
Halloran Benefits and Perks:
The benefits of being a Halloran employee go beyond the unparalleled opportunities of your day to day work! We offer an annual, discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, and a 401(k) Plan for all full-time employees. We offer reimbursements for Health & Wellness Programs and Memberships, opportunities for continued learning through conference and continuing education programs. We also offer a Self-Managed PTO Policy, Commuter FSA Benefits, and many other benefits.
Halloran Consulting Group, Inc. COVID-19 Considerations:
Successful applicants for employment must provide proof of full COVID-19 vaccination as a condition of entering Halloran’s offices, attending Halloran sponsored events (at Halloran offices or otherwise), and traveling to client sites, subject to requests for accommodation. Individuals will be considered fully vaccinated two weeks after a second shot of a two-shot vaccine regimen (i.e., Pfizer or Moderna) or two weeks after a single shot of the Johnson & Johnson vaccine.
Halloran does not sponsor visas for employees.
All remote employees are expected to have a consistent home internet connection with speeds of at least 25Mbps while working remotely.
We are committed to equal employment opportunities for all applicants and employees. We do not discriminate against employees or applicants for employment based on any protected class including, but not limited to, race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age, veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by an authorized representative of Halloran.