Senior/Principal Medical Writer
Proclinical is currently recruiting for a Senior/Principal Medical Writer with a global biopharmaceutical company located remotely. As the Senior/Principal Medical Writer, you will author complex regulatory documents ensuring the coordination and integration of the scientific, medical and regulatory input from development team members and to support the performance goals for filing regulatory dossiers as planned by the Development Teams.
- Work with project teams to prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, briefing books, other documents for INDs/IMPDs, NDAs/BLAs according to health authority guidelines to support drug development.
- Contribute scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.
- Provide leadership in completing major summary submission documents (e.g., pivotal study reports, Clinical Summary of Efficacy, Clinical Summary of Safety, and Clinical Overview) to support high-quality submission dossiers.
- Ensure a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards.
- Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
Skills and Requirements:
- Masters or PhD in life sciences required.
- At least 4 years of relevant medical writing experience is required.
- Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
- Strong organization and prioritization skills with a demonstrated ability to work in a fast-paced, rapidly changing environment is required.
- Proven learning agility with the ability to quickly assimilate and apply knowledge is required.
- Solid knowledge and application of regulatory guidance documents such as ICH requirements is required.
- Experience in oncology area preferred.
- Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
- Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment.
- Demonstrated leadership, problem-solving ability, to work simultaneously on multiple projects, and the ability to prioritize tasks leading to timely completion of high-quality documents.
If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929-223-4835 or firstname.lastname@example.org.
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.