Principal Medical Writer - 6 Month Contract
Proclinical is currently recruiting for a Principal Medical Writer with a pharmaceutical company located in Cambridge, MA. Successful candidate will assume primary medical writing responsibility for preparation of key regulatory response documents and strategic documents supporting major regulatory submissions.
- Leads a single team which guides medical writing activities within a designated therapeutic area for key response documents and regulatory submissions.
- Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
- Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
- Coordinates and provides oversight for the activities of medical writing vendor(s) (, and ensures resolution of issues.
- As required, serves as lead writer for strategic regulatory documents and key components of regulatory submissions.
- Provides leadership on functional teams that address requirements or issues related to document preparation and production.
- The Principal Medical Writer Program Lead is seen as an expert in medical writing and performs work independently with minimal supervision.
Skills and Requirements:
- Bachelor's degree in science, health profession, or journalism required.
- 5+ years' experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
- Experience as lead writer for key documents included in major US and/or international regulatory submissions required
- Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
- Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
- Ability to understand Takeda guidelines and requirements related to the preparation and production of regulatory documents and submissions.
- Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
- Knowledge of team dynamics and ability to function as a team leader.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4835 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.