Job Description
Role Description
- The Senior Medical Writer, Medical Writing is accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval.
- Responsible for the development of high-quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including but not limited to Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments.
- Collaborate with Global Development Teams and Clinical Development to ensure alignment with program objectives.
- Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
- Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
- Owns and updates assigned Medical Writing SOPs, as necessary.
- Qualifications
- Bachelor’s Degree in life science, health-related or pharmaceutical field, or the equivalent in experience.
- Minimum of 3 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
- Previous experience in Medical Writing in clinical drug development, preferably some experience in oncology.
- Working knowledge of Medical Writing requirements and document components.
- Experience with templates and template development, and document management systems.
- Excellent writing skills.
- Good interpersonal skills that involve working well in a team environment and the ability to lead others.
- Good organizational and planning skills; drive for results.
- Ability to read, analyze and interpret scientific and technical information.
- Effective analytical/problem solving skills.
- Ability to write procedures.
- Ability to follow instructions and synthesize information from multiple sources.
- Strong PC skills including intermediate/advanced proficiency with MS Word, and basic proficiency with other MS Office products. Adept in learning additional software utilized at Taiho.
- Requirements
- The pay range for this position at commencement of employment is expected to be between $116,450 - $137,000 annually.
- This pay range is based on the market range for positions of this type.
- Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
- The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
- Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
- If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Benefits
Apply tot his job
Apply To this Job