Job Title Senior Medical Writer Job Description
As the Senior Medical Writer, you will
be responsible
for
author
ing
technical documents that support
th
e
US,
European Union
(
EU
)
and other international
regulatory submissions of Philips Ambulatory Monitoring and Diagnostics (AM&D)
division.
You will also
mentor junior medical writers and
collaborate with
AM&D
Medical Affairs in
writ
ing scientific communication documents such as ma
nuscripts,
abstracts,
and podium presentations.
Your role:
Author Clinical Investigation Plan (CIP) for all upcoming AM&D clinical trials
Author Pre m
arket Application (PMA),
510k Premarket Submission,
Clinical Study Report (CSR)
,
Annual Progress Report (APR)
Author Clinical Evaluation documents for
existing and
new products and
maintain
/update existing company
Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) Plans and PMCF Reports
according to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR
You're the right fit if:
You have an MS
Degree in scientific or medical discipline with at least
6
years of experience in
the medical device industry
focusing on
clinical evaluation report writing or
scientific
writing and/or
PhD, MD, PharmD, or equivalent with at least
4
years of related
experience
I
n dep
th
e
xperience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.)
,
critically assess
findings
and
research
methodology
experience (including clinical investigation design and biostatistics)
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this
position .
Excellent written and oral communications skills
;
strong attention to detail related to consistency, grammar, syntax, and accuracy, strong skills working in a team environment, including leading discussions and presenting to internal business and regulatory stakeholders
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about
our business .
Discover
our rich and exciting history.
Learn more about
our purpose.
Read more about
our employee benefits .
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion
here .
Philips Transparency Details
The pay range for this position is $106,000 to $180,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found
here
.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits
will not
be provided for this position. For this position, you must reside in
or
within commuting distance to San Diego, CA .
Philips is an
Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an
Equal Employment and Opportunity
Employer/Disabled/Veteran
and maintains a drug-free workplace.
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