Post-Market Safety Evaluation Principal Medical Writer
Abbott
- Saint Paul, MN
- $95,000-190,000 per year
- Permanent
- Full-time
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
- Facilitates communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, Product Performance Group (PPG), Sales and Marketing, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers).
- Propose and implement process improvements, identifying CFT members, obtaining stakeholder agreement, presenting recommendations to upper management, and executing steps to implement.
- Oversees COs, actively manages timelines and project delays/risks, and develops scenarios and recommendations for management.
- Creates, manages, or participates in PSUR/PMS Report timelines and budgets by selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines.
- Maintains up-to-date understanding and experience of clinical / PMS data and risk management.
- Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
- Develops and maintains PSUR/CASR/PMS Report/PMS Plan DOPs/SOPs and associated documentation; provides input to cross-departmental SOPs and DOPs as needed; leads and oversees the process improvement to CASRs.
- Independently creates and maintains PSURs, PMS Reports, CASRs, and PMS Plans for Abbott products. Maintain thorough knowledge of assigned products. Identify appropriate sources of relevant data, interpret, evaluate, and incorporate information from various sources including literature, clinical data, and medical references.
- Participates in and supports audits. May actively participate in root cause analysis. May participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.
- Bachelor’s Degree
- 8 years’ experience in the medical device industry
- 6 years of significant medical writing experience
- Advanced degree
- Must have well developed written, oral, interpersonal and negotiation skills.
- Leadership competency including organizational development and project management skills.
- Demonstrated ability to identify and adapt to shifting priorities and competing demands.
- Highly developed interpersonal skills, and strong attention to detail.
- Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Minnesota
St. Paul
Tech Center : One St Jude Medical DriveADDITIONAL LOCATIONS: United States
Texas
Plano : 6600 PinecrestWORK SHIFT: StandardTRAVEL: Yes, 5 % of the TimeMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf