Medical Affairs Manager / Medical Writer (Remote Opportunity)
Job Description Summary
Reporting to the Senior Manager, The Medical Affairs Manager for Endourology & TTM ensures efficient and compliant outputs for the Medical Affairs function. This includes writing of Clinical Evaluation Plans, Reports, Policies, and Procedures. The Manager function strives to increase the value and impact of Medical affairs activities by leading, developing and mentoring a team of medical writers to support post-market products and new product development.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Manages a team of Medical Affairs direct reports to support the clinical and scientific requirements for the Endourology and TTM Franchises.
Supervises the development and maintenance of clinical evaluation plans and reports in accordance with the requirements of MEDDEV 2.7.1 Rev 4 and EU MDR
Provides guidance on what forms of evidence to be included / excluded for clinical evaluation.
Provides guidance on PMCF recommendations.
Assigns MA functional team members for CEPs, CERs, Post-Market Surveillance (PMS) teams, TD Remediation Project Teams, and New Product Development (NPD) teams, Clinical Impact Assessments, and audit-related tasks.
Participates as CER writer, MA representative for PMS Project Teams, EU MDR Remediation Teams, Clinical Impact Assessment reviewer, MA representative for NPD teams, Audit-related tasks, Other clinical impact responsibilities as required.
Responsible for tracking status of all assigned tasks and reporting metrics to senior management and/or corporate as requested.
Participates as Medical Affairs Independent Reviewer for EU MDR Design Reviews as required.
Drives updates and revisions to all applicable forms of SOPs in order to maintain compliance to EU MDR, MEDDEV 2.7.1 Rev 4 re Quality System Regulations, ISO Requirements, International Regulations, FDA Regulations, and Corporate/Division policies and procedures.
Liaison with the Post-Market Clinical Follow-up (PMCF) Specialists to ensure accurate and adequate recommendations for any needed PMCF activities.
Liaison with the SSCP lead to ensure accurate and on-time completion of Summary of Safety and Clinical Performance (SSCP) functional reviews.
Interface with Corporate Medical Affairs on developing revising processes, policies, and procedures.
Support and contribute to applicable regulatory submissions (IDE, PMA, CER, etc.) reports and responses to regulatory authorities.
Provide strategic input and technical guidance on clinical requirements to product development teams.
Audit and Compliance Responsibilities:
Leads UCC Medical Affairs Quality and Compliance activities, including audit readiness.
Leads audit response communication and oversees the implementation of audit-related process improvements.
Approve and review Audit Action Plans for internal and external audits for Medical Affairs function.
Ensures maintenance of the UCC MA training records, documentation, and systems.
Acts as a Medical Affairs contact person for UCC activities related to quality & compliance.
Schedules regular check-ins with direct reports.
Perform all required Performance Management Process (PMP) activities for all direct reports.
Leads the recruiting effort for new medical affairs associates in the Endourology and TTM team, as needed.
Responsible for the onboarding and training of new direct reports.
EXPERIENCE & EDUCATION:
Must have an MD, PhD, or Doctor of Pharmacy degree.
A minimum of 2 years’ experience in Medical Affairs.
Training and / or experience of working with Urology medical devices is strongly preferred.
KNOWLEDGE, SKILLS AND ABILITIES:
Strong understanding of MEDDEV 2.7/1 Rev 4, MDD, and EU MDR
Must have strong written and verbal communication skills
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA GA - Covington BMD
Recommendto a friend
"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ