Associate Director / Senior Manager, Medical Writing
Proclinical is currently recruiting for an Associate Director/Senior Manager of Medical Writing for a biopharmaceutical company located in Gaithersburg, MD. Successful candidate will provide expert communications leadership to drug projects and drive strategic medical writing, advocating communications excellence in your team.
- Ensure that clinical documents align with project strategies, meet regulatory requirements and adopt best communications practices.
- Lead the authoring of clinical documents. Write clinical regulatory and other supporting documents/submissions for assigned studies/indications for one or more programs/molecules and manage the overall development and approval process. Critically analyze, synthesize, and present complex information from a broad range of scientific disciplines and therapeutic areas.
- Provide critical review of documents from authors assigned to document deliverables for correctness, clarity, completeness and compliance. Drive consistency across projects/programs.
- Manage service providers/contractors as needed.
- Lead continuous improvement within the department and across the organization. Uses submissions-related expertise to improve document quality and process efficiency. Ensure adherence of document to standards and processes.
- Mentor staff, encouraging strong performance through motivation of others and leading by example. Requirements Essential To join us as a MCS, you should have solid experience writing regulatory documents at study-level, with a good understanding of pharmaceutical drug development.
Skills and Requirements:
- Bachelor's degree in the life sciences, preferably with an MSc or PhD.
- Demonstrated regulatory writing experience gained within the pharmaceutical/medical industry/CRO.
- Willingness to undertake domestic and international travel as required by the project. This role is available at Senior or Associate Principal career level, dependent on experience.
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.