Job Information
Philips Clinical Development Scientist/Medical Writer in Cambridge, Massachusetts
Clinical Development Scientist/Medical Writer (Cambridge, MA or Pittsburgh, PA office-based)
The Clinical Development Scientist/Medical Writer is responsible for analyzing clinical trial protocols and studies to ensure regulatory compliance and strategic alignment, working under some supervision. The role excels in crafting comprehensive and compliant Clinical Evaluation Documents, Clinical Study Reports, and regulatory submissions using advanced proficiency in software tools and adherence to standards.
Your role:
Analyzes clinical trial protocols and studies, ensuring adherence to regulatory requirements and alignment with strategic objectives, providing recommendations for protocol optimization and enhancement.
Crafts comprehensive and compliant CER’s, CSRs, and clinical sections of regulatory submissions, employing advanced-level proficiency in standard software tools and systems, adhering to internal procedures, templates, and external standards, regulations, and guidance.
Troubleshoots complex issues related to clinical data collection, analysis, and reporting, leveraging analytical skills to ensure data integrity, accuracy, and consistency across studies, working under some supervision.
Assesses and critically analyzes clinical study data within the clinical study report, synthesizing findings to support dissemination efforts such as abstracts, white papers, and peer-reviewed publications, contributing to the advancement of scientific knowledge.
Develops Clinical Development and Market Access strategies, referencing applicable business processes, and contributes to the development of clinical protocols in accordance with relevant standards and regulations, ensuring strategic alignment and regulatory compliance.
Performs comprehensive literature searches and in-depth reviews to support evidence generation processes for both New Product Introduction (NPI) and Life Cycle Management (LCM) initiatives, providing critical insights and evidence-based support for decision-making.
Supports relationships with Key Opinion Leaders (KOLs) and Investigators, facilitating the execution of clinical studies and ensuring robust data generation, contributing to the credibility and success of clinical development programs.
Interact closely with colleagues to determine and implement optimal approaches for evidence generation and clinical study design, promoting a culture of innovation and excellence within the clinical development team.
Presents findings from literature reviews and data analyses to internal stakeholders, contributing to informed decision-making processes and strategic discussions.
Disseminates evidence derived from clinical studies, effectively communicating the impact and significance of findings to internal teams and external stakeholders, contributing to the broader scientific community and market understanding.
You're the right fit if:
You’ve acquired 1+ years of experience in medical writing and clinical development in the medical device industry. Experience with Software as a Medical Device (SaMD) and purely software based medical device products is preferred.
Your skills include experience authoring Clinical Evaluation Plans and Reports (CER/CEP), Clinical Study Reports (CSR), and Post Market Clinical Follow-Up Plans and Reports (PMCFP/PMCFR).
You have a master’s degree or higher in a life science field required, PhD/MD preferred.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
You’re an excellent communicator, with an ability to work effectively in a highly matrixed organization, and influence without having expressed authority.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office-based role.
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.
Learn more about our culture.
Philips Transparency Details
The pay range for this position in Pittsburgh, PA is $101,250 to $162,000
The pay range for this position in Cambridge, MA is $113,400 to $181,440
The actual base pay offered may vary within the posted ranges 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.
Additional Information
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 Pittsburgh, PA or Cambridge, MA .
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It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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