Penfield Search Partners
Contact: Linda Aronova 646.882.9021 email@example.com
Summary: The Principal Medical Writer/Associate Director will report to the Head of Medical Writing. Responsibilities will include development of clinical-regulatory documents and clinical communications in support of company’s early and late-stage drug development programs as well as to support medical writing departmental processes and infrastructure.
- Development of clinical protocols and amendments, clinical study reports, investigator brochures, clinical sections of IND/NDA and other documents to support global product development.
- Assist with the development of abstracts, slides, and posters for clinical data presentation at medical conferences.
- Assist with oversight of manuscripts for publication in peer-reviewed journals.
- Partner with biostatistics for early planning and input for SAP and review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents.
- Work closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
- With minimal oversight, act as lead on assigned projects to drive the overall process for document development including timelines, content development, document review, and approvals.
- Prepare documents in accordance with internal standards and external regulatory guidelines.
- Develop and implement document templates, style standards, reference library, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables.
- Assist with external vendor oversight as applicable.
Education, Experience, and Skills:
- Minimum of 8-10 years of clinical experience within medical writing (Sponsor or CRO).
- Bachelors degree in life sciences; Masters or doctorate degree qualification in life sciences is preferred.
- Expertise in preparing clinical-regulatory documents and/or scientific publications.
- Prior IND/NDA/MAA submission experience preferred.
- Excellent written and verbal communication skills.
- Strong ability to interpret and present statistical and clinical data.
- Fluency in Microsoft Word, PowerPoint, and Adobe Acrobat.
- Excellent project management skills to organize work and to influence and guide teams during document development.
- Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships.
- Advanced knowledge of FDA regulations, ICH guidelines, Good Clinical Practices, medical terminology, and the drug development process.
- Ability to multi-task in a fast-paced environment.
- Consideration given to candidates with therapeutic experience in kidney disease.