Medical Writing and Scientific Lead
Proclinical is currently recruiting for a Medical Writing and Scientific Lead for a pharmaceutical company located in Boston, MA. Successful candidate will be responsible for medical writing activities that support the company business objectives within a project, including responsibility for the direction, scope, and organization of documents in consultation with the project physician, statistician, and other team members as appropriate.
- The Medical Scientific Writing Lead ensures that clinical regulatory documents (eg, study reports, study protocols, clinical summaries/overviews, investigator's brochures, scientific publications, contributions to response documents, and other global regulatory submission documents as appropriate) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure.
- The activities of the Medical Scientific Writing Lead (performed with minimal supervision) include, but are not limited to: writing, development of timelines, project management, and participation on project teams.
- The Medical Scientific Writing Lead ensures the timely delivery of high-quality documents that are scientifically rigorous and logically organized, with accurate data presentation and interpretation.
- In addition to project responsibilities, the Medical Scientific Writing Lead may participate in departmental or cross-functional initiatives designed to establish highly efficient processes, best practices, and productive cross-functional collaboration.
- The Medical Scientific Writing Lead may have responsibility for oversight of external service providers.
- Participate in the preparation of responses to questions from regulatory agencies
- Provide oversight of medical writing tasks on studies that are outsourced to partners
- Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance. Procedures and practices meet industry standards and are consistent with internal SOP.
Skills and Requirements:
- 8+ years of experience in clinical/pharmaceutical development with directly related medical/scientific writing experience
- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor's degree required.
- Global regulatory submission experience
- Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
- Must have a working knowledge of medical writing tasks as part of the FDA submission packages
- Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed.
- Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
The position must demonstrate
- Excellent verbal and written communication skills
- Experience in the analytical evaluation of analysis of clinical study data
- Exceptional organizational skills and attention to details
- Project management skills and familiarity with GCP and ICH guidelines
- Manage multiple projects with competing priorities
- Show competency in leadership and mentoring other team members
- Ability to work with minimal supervision as well as in a team
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.