Vacature Manager

Manager, Medical Writing

About Pharming

Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Pharming is committed to our core values: "We Care, We Collaborate, We Walk the Talk", which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a meet our strategic goals and objectives.

Pharming is seeking to hire a Manager, Medical Writing . Our goal is to have the incumbent support the authoring and development of documentation required for regulatory submissions based on scientific knowledge and applicable global regulatory guidance as well as legislation through all phases of development and post-approval across global markets. Successful execution will involve partnering cross-functionally across the organization to ensure key messaging among submission documentation. The position is an individual contributor role and reports to the Senior Director, Labeling and Operations.

The Manager, Medical Writing will be responsible for a wide variety of matters in support of Pharming's growth as we increase the number of both pipeline and marketed products.

Core functions include:

• Responsible for the authoring, editing, and finalization/approval of medical writing deliverables intended for final disposition to Health Authorities in support of regulatory submissions.
• Has an in-depth understanding of complex scientific information and development data to expertly author documentation clearly, including incorporating key messaging.
• Develops authoring timelines aligned to company strategic goals, including key regulatory milestones and activities.
• Acts as medical writing subject matter expert on cross-functional teams to provide guidance and recommendations on document authoring activities.
• Contributes to submissions, including Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), regulatory meeting documents, registration filings, and supplements/amendments thereof, as well as abstracts, publications, and/or presentations.
• Coordinates with the Regulatory Operations team to ensure timely and accurate submissions to Health Authorities.
• This is a hybrid role; 2 to 3 days at Warren, NJ office.

Minimum Qualifications:

• Advanced scientific degree in a life sciences or technical field from an accredited university.
• 5+ years related experience in medical writing for regulatory submissions.

Preferred Qualifications:

• Rare disease or specialty pharmaceutical experience preferred.
• Knowledge of Global Health Authority requirements for pharmaceuticals and biologics.
• Essential Skills Certification, RAC certification, and Certified Medical Publication Professional™ (CMPP™) is a plus.
• AMWA and The International Society for Medical Publication Professionals (ISMPP) membership is a plus.
• Excellent verbal and written communication skills, strong interpersonal skills, and tactful negotiation skills.
• Ability to travel up to 10%.

Compensation & Benefits:

• Flexible hybrid work schedule to promote a health work-life balance.
• Competitive compensation package including annual target bonus.
• Long-Term Incentive Program
• 401(k) plan with company match
• Paid-Time Off Days
• 16 Company Holidays per year (typically last week of December up until New Year's Day)

• Excellent Healthcare Plans including Medical, Dental and Vision.
• Flexible Spending Accounts for Medical and Dependent Care.
• Company-provided Life Insurance, Short-Term and Long-Term Disability Plans.
• Accident, Hospital Indemnity and Critical Illness Plans.
• Pet Insurance Plan.
• On Premise Fitness Center.
• Health & Wellness Program.
• Choice of Mobile Phone for Work Use or Cell Phone Stipend.
• Pharming Academy - Continuing Learning & Development Program.

Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to .

Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

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Cookie Consent Manager

Functie:	manager
Startdatum:	1-11-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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