Clinical Medical Writer

Location
Cambridge, MA
Posted
Oct 04, 2019
Required Education
Bachelors Degree
Position Type
Full time

Clinical Medical Writer
Cambridge, MA

Your role:
At Miltenyi Biotec, 2,500 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases. In the newly created Miltenyi Biomedicine division, we focus on the development and marketing of cell therapeutics.

• You collaborate with other members of the cross-functional teams to prepare high quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents.
• You participate in scientific communication planning and development of strategic medical communication plans.
• You ensure that the medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines.
• You also will develop and maintain strong, collaborative relationships with key stakeholders.

Your profile:
• You hold Bachelor’s degree in a science related discipline or advanced degree preferred and have a minimum of 2 years of medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas and experience managing the medical writing responsibilities associated with multiple studies at various stages; or equivalent combination of education and experience.
• You possess cross therapeutic experience including immunotherapies, infectious disease, or vaccine trials and a thorough knowledge of FDA and ICH GCP guidelines.
• You have proven experience in early phase drug development, regulatory GCP inspections/audits, and multi-dimensional clinical operations background with the capability of devising plans for operational challenges.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands and fingers, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs must be followed and PPE must be worn.


Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity