Director Medical Writing & Clinical Development
Director Medical Writing & Clinical Development
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$ 184800 - 295680
1 Vacancy
Job Description
Job Title
Director Medical Writing & Clinical DevelopmentJob Description
The Director Medical Writing & Clinical Development is a key member of the Ultrasound Medical and Clinical Affairs team and serves as a subject matter expert mentor and strategic guide that integrates multiple data and evidence streams (published literature society guidelines Philips clinical studies Real-World Data) to support all aspects of Clinical Development (clinical opportunity identification evidence generation and surveillance/safety).
Your role:
- Leads the medical writing team in planning and delivering high-quality compliant documents through effective resources budget and timeline management.
- Compiles and analyzes clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4 EU Medical Device Regulation).
- Author and maintain clinical documentation including Clinical Evaluation Plans and Clinical Evaluation Reports Post-market Clinical Follow-up Plans/Reports and Investigator Brochures contributing to Risk Management and Post-Market Surveillance activities.
- Drives collaboration and knowledge-sharing across medical clinical and regulatory teams including Medical Affairs Clinical Development Research & Development and Regulatory Affairs.
- Develops clinical evidence strategies for New Product Introductions including performance claims and coordination on usability and non-clinical evidence.
- Collaborates with cross-functional teams to ensure regulatory compliance and to define medical writing scope and clinical evidence strategy.
- Optimizes medical writing processes by identifying and implementing automation standardization and workflow efficiencies.
- Translates complex scientific data into clear impactful narratives for regulatory bodies clinicians and stakeholders to support product development and commercialization
Youre the right fit if:
- Youve acquired a minimum of 10 years combined experience working within FDA regulated medical device and clinical environments with a focus on the development of clinical evidence/documents (manuscripts scientific abstracts conference presentations/posters reports based on clinical studies and data/analytics).
- You have detailed knowledge of medical device regulations requirements and standards for FDA and EU especially for medium risk devices (Class II/Class IIA) focused on AI/software and information products.
- You have proven strategic/functional management experience in building and developing highly organized and capable teams. Experience in project management (a plus if you have experience in agile) mentoring training performance management and development of team members.
- You have a demonstrated track record of learning agility and comfort in taking on /shaping complex/uncertain business problems and creating creative/pragmatic solutions.
- You have a passion for simplification and optimizing processes and workflows identifying opportunities for automation and software tools that improve productivity compliance and reduce time to market.
- You have a minimum of a Masters degree in life sciences or equivalent discipline (REQUIRED).
- Preferred experience: Background in Real-World Data/Analytics (such as Epidemiology Health Services Research Health Economics or Medicine) and healthcare quality management background and familiarity with agile tools (Azure Dev Ops/Jira) information management (Confluence Distiller Endnote) or dashboarding/visualization (Tableau PowerBI).
- You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together:
We believe that we are better together than a part. For our Office-based teams this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations. This is an Office role.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality of 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 Cambridge MA and Bothell WA is $184800 to $295680.
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.
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.
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.
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 Bothell WA or Cambridge MA.
- This role may require travel up to 10%.
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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 including Disability/Vets and maintains a drug-free workplace.
Required Experience:
Director
Employment Type
Full-Time
