Job Description

1. Medical Writing experience with EU MDR Deliverables (PMCF Plans, PMCF Reports, Clinical Development Plans or Clinical Evaluation Reports (CER) or Publications/Grant writing experience.

Rationale: The primary responsibilities of this individual will be to write PMCF Plans, PMCF Reports, and Clinical Development Plans with data generated for Medical Devices. In lieu of direct experience with these documents, I would like the candidate to atleast have worked on a Clinical Evaluation Report or have scientific writing experience with publications/grants.

2. High level of attention to detail and has extensive experience using Microsoft word and excel.

Rationale: Clinical Affairs at client have a reputation of putting out high quality documents. Thus, a successful person needs to be detail orientated and be able to identify/resolve discrepancies when found. We also use a lot of templates in word that require nesting of tables and keeping information organized within the templates. Having a strong background in formatting/working with word and excel will help with maintaining high level of quality that is expected.

3. Experience working cross-functionally and with quality control.

Rationale: The documents this individual would create get reviewed by cross-functional team members across Abbott and a third-party vendor for Quality Check. This person would be working directly with these individuals to resolve questions and make the associated edits.

With hiring for these positions in the past, we have found that individuals with advanced degrees i.e. PhDs tend to have the experience we are looking for. However, I am happy to review individuals who have significant relevant experience in lieu of an advanced degree.

Location – Remote

HM is looking for someone with ~5 years of experience, but he has indicated that he is willing to evaluate candidates with less experience, if they have an advanced degree (MD/PhD).

Experience in Regulatory Affairs con be considered but a person with Clinical Background is preferred.

Job Description

• This role is specific to EU Medical Device Regulation (MDR) post market clinical follow up (PMCF) planning and reporting.
• Must feel comfortable collecting, analyzing, and writing up data into reports, as well as planning for future data collections
• Will act as Clinical Affair's representative to cross-functional meetings for regulatory submissions.
• Must be comfortable developing and managing timelines for deliverables and interfacing with cross-functional teams on a a regular basis ? Willing to consider candidates remote

Job Type: Contract

Salary: $80.00 - $95.00 per hour

Schedule:

• 8 hour shift
• Day shift

Education:

• Bachelor's (Preferred)

Experience:

• PMCF Plans, PMCF Reports: 5 years (Preferred)
• Clinical Evaluation Reports (CER): 5 years (Preferred)
• Medical Device industry: 5 years (Preferred)
• EUMDR: 4 years (Preferred)

Work Location: Remote

Similar Jobs